hydroxyurea has been researched along with Erythremia in 372 studies
| Excerpt | Relevance | Reference |
|---|---|---|
| "Hydroxyurea (HU) treatment of patients with essential thrombocythemia (ET), polycythemia vera (PV), and primary myelofibrosis (PMF) (MPNs) normalizes elevated blood cell counts within weeks in the large majority of patients." | 9.41 | Data-driven analysis of the kinetics of the JAK2V617F allele burden and blood cell counts during hydroxyurea treatment of patients with polycythemia vera, essential thrombocythemia, and primary myelofibrosis. ( Andersen, M; Dam, MJB; Hasselbalch, HC; Kjaer, L; Knudsen, TA; Ottesen, JT; Pedersen, RK; Skov, V, 2021) |
| "Ruxolitinib, a potent JAK1/JAK2 inhibitor, was found to be superior to the best available therapy (BAT) in controlling hematocrit, reducing splenomegaly, and improving symptoms in the phase 3 RESPONSE study of patients with polycythemia vera with splenomegaly who experienced an inadequate response to or adverse effects from hydroxyurea." | 9.27 | Ruxolitinib is effective and safe in Japanese patients with hydroxyurea-resistant or hydroxyurea-intolerant polycythemia vera with splenomegaly. ( Amagasaki, T; Gadbaw, B; Handa, H; Hino, M; Ito, K; Kirito, K; Miyamura, K; Okamoto, S; Suzuki, K; Takeuchi, M; Yamauchi, K, 2018) |
| "Therapeutic options for patients with polycythemia vera (PV) and essential thrombocythemia (ET) resistant or intolerant to hydroxyurea are limited." | 9.19 | Busulfan in patients with polycythemia vera or essential thrombocythemia refractory or intolerant to hydroxyurea. ( Alvarez-Larrán, A; Ancochea, A; Angona, A; Antelo, ML; Bellosillo, B; Besses, C; Burgaleta, C; Cervantes, F; Durán, MA; Ferrer-Marín, F; Gómez, M; Gómez-Casares, MT; Hernández-Boluda, JC; Marcote, B; Martínez-Avilés, L; Martínez-Trillos, A; Mata, MI; Senín, A; Vicente, V; Xicoy, B, 2014) |
| "The overall impact of hydroxyurea (HU) or pipobroman treatments on the long-term outcome of patients with polycythemia vera (PV) has not been assessed in randomized studies." | 9.15 | Treatment of polycythemia vera with hydroxyurea and pipobroman: final results of a randomized trial initiated in 1980. ( Chevret, S; Chomienne, C; Dosquet, C; Kiladjian, JJ; Rain, JD, 2011) |
| " The aims of this study were (1) to detect involvement of N- and K-ras mutations in codons 12 and 13 in the pathogenesis of the chronic and blastic phases of PV and ET, (2) to study the occurrence of microsatellite instability (MSI) in chromosomes 5 and 7 during the chronic phase and blastic transformation of the disease, and (3) to examine the incidence of leukemia in patients treated with hydroxyurea (HU)." | 9.10 | Leukemogenic risk of hydroxyurea therapy as a single agent in polycythemia vera and essential thrombocythemia: N- and K-ras mutations and microsatellite instability in chromosomes 5 and 7 in 69 patients. ( Loukopoulos, D; Madzourani, M; Mavrogianni, D; Meletis, J; Michali, E; Pangalis, G; Terpos, E; Vaiopoulos, G; Viniou, N; Yataganas, X, 2002) |
| "The in vivo effects of hydroxyurea (HU) on circulating erythroid (BFU-E) and granulocyte-macrophage progenitors (CFU-GM) in patients with polycythemia vera (PV) have been evaluated." | 9.08 | Circulating hematopoietic progenitor cells in polycythemia vera: the in vivo effect of hydroxyurea. ( Bogliolo, G; Castello, G; Cavallini, D; Cerruti, A; Lerza, R; Pannacciulli, I, 1995) |
| "Nonradiomimetic drugs, hydroxyurea (HU) and pipobroman (Pi), were administred to relatively young subjects with polycythemia vera (PV) in an attempt to decrease the leukemogenic risk observed in patients treated with 32P." | 9.08 | Treatment of polycythemia vera: the use of hydroxyurea and pipobroman in 292 patients under the age of 65 years. ( Najean, Y; Rain, JD, 1997) |
| "Between 1980 and 1991, 96 patients with documented polycythemia vera were treated by hydroxyurea or pipobroman, according to a protocol including randomization, and maintenance therapy." | 9.07 | [Treatment of polycythemia vera with hydroxyurea or pipobroman. Efficacy and toxicity analysed from a protocol of 96 patients under 65 years of age. Le Groupe d'Etude des Polyglobulies]. ( Najean, Y, 1992) |
| "Hydroxyurea is the standard treatment in high-risk patients with polycythemia vera." | 9.01 | Clinical outcomes under hydroxyurea treatment in polycythemia vera: a systematic review and meta-analysis. ( Barbui, T; Carobbio, A; De Stefano, V; Ferrari, A; Finazzi, G; Ghirardi, A; Masciulli, A; Vannucchi, AM, 2019) |
| "Hydroxyurea (HU) has traditionally been the first-line treatment for patients with polycythemia vera (PV) or essential thrombocythemia (ET) at high risk for vascular complications." | 8.90 | Therapeutic options for patients with polycythemia vera and essential thrombocythemia refractory/resistant to hydroxyurea. ( Newberry, KJ; Sever, M; Verstovsek, S, 2014) |
| "Hydroxyurea is an old drug that is often used to control essential thrombocythemia and polycythemia vera in patients with high-risk disease." | 8.83 | Hydroxyurea: The drug of choice for polycythemia vera and essential thrombocythemia. ( Dingli, D; Tefferi, A, 2006) |
| "Hydroxyurea (HU) is effective in controlling thrombocytosis while reducing the risk of thrombosis in essential thrombocythemia (ET), polycythemia vera (PV) and myelofibrosis (MF)." | 8.83 | Leg ulcers in elderly on hydroxyurea: a single center experience in Ph- myeloproliferative disorders and review of literature. ( Fabris, F; Luzzatto, G; Randi, ML; Ruzzon, E; Scandellari, R; Tezza, F, 2006) |
| "Retrospective, descriptive study of the medical records of patients who developed leg ulcers while receiving hydroxyurea therapy." | 8.80 | Hydroxyurea-induced leg ulceration in 14 patients. ( Best, PJ; Daoud, MS; Petitt, RM; Pittelkow, MR, 1998) |
| "Ruxolitinib is approved for patients with polycythemia vera (PV) who are resistant/intolerant to hydroxyurea, but its impact on preventing thrombosis or disease-progression is unknown." | 8.12 | Real-world analysis of main clinical outcomes in patients with polycythemia vera treated with ruxolitinib or best available therapy after developing resistance/intolerance to hydroxyurea. ( Alvarez-Larrán, A; Angona, A; Arellano-Rodrigo, E; Ayala, R; Bellosillo, B; Caballero, G; Carreño-Tarragona, G; Cuevas, B; Del Orbe-Barreto, R; Ferrer-Marín, F; Fox, ML; García, R; García-Gutiérrez, V; García-Hernández, C; Garrote, M; Gasior, M; Gómez, M; Gómez-Casares, MT; Guerrero, L; Hernández-Boluda, JC; Magro, E; Martínez, CM; Mata-Vazquez, MI; Murillo, I; Pereira, A; Pérez-Encinas, M; Pérez-López, R; Ramírez, MJ; Raya, JM; Xicoy, B, 2022) |
| "To determine the prevalence, clinical outcomes, and factors associated with hydroxyurea (HU) resistance or intolerance among polycythemia vera (PV) and essential thrombocythemia (ET) patients." | 8.12 | Prevalence and clinical outcomes of polycythemia vera and essential thrombocythemia with hydroxyurea resistance or intolerance. ( Chai-Adisaksopha, C; Chiaranairungrot, K; Hantrakool, S; Kaewpreechawat, K; Norasetthada, L; Pagowong, N; Piriyakhuntorn, P; Rattanathammethee, T; Rattarittamrong, E; Sajai, C; Sukarat, N; Tantiworawit, A, 2022) |
| "Hydroxyurea is a chemotherapeutic agent used for myeloproliferative disorders and sickle cell anemia that is well known to cause painful mucocutaneous ulcers, typically involving the legs or mouth." | 8.02 | Hydroxyurea-induced genital ulcers and erosions: Two case reports. ( Blum, AE; Kemp, JM; Tsiaras, WG, 2021) |
| "Approximately one-quarter of patients with polycythemia vera become resistant to and/or intolerant of hydroxyurea." | 8.02 | Real-World Dosing Patterns of Ruxolitinib in Patients With Polycythemia Vera Who Are Resistant to or Intolerant of Hydroxyurea. ( Altomare, I; Colucci, P; Kish, J; Lord, K; Paranagama, D; Parasuraman, S; Yu, J, 2021) |
| "This study aimed to evaluate real-life data on patterns of hydroxyurea prescription/use in polycythemia vera (PV)." | 7.96 | Patterns of Hydroxyurea Prescription and Use in Routine Clinical Management of Polycythemia Vera: A Multicenter Chart Review Study ( Ali, R; Altuntaş, F; Ar, MC; Ayyıldız, O; Büyükaşık, Y; Çiftçiler, R; Gökçen, E; Güven, Z; Karakuş, A; Mastanzade, M; Meletli, Ö; Okay, M; Saydam, G; Soyer, N; Soysal, T; Tuğlular, T; Turgut, M; Uçar, B; Ünal, A; Yavuz, AS; Yiğenoğlu, TN, 2020) |
| "Hydroxyurea (HU) resistance or intolerance occurs in 15 to 24% of patients with polycythemia vera (PV)." | 7.91 | Polycythemia vera and hydroxyurea resistance/intolerance: a monocentric retrospective analysis. ( Delforge, M; Demuynck, T; Devos, T; Vandenberghe, P; Verhoef, G, 2019) |
| "Criteria of response and definition of resistance and intolerance to hydroxyurea (HU) in polycythemia vera (PV) were proposed by the European LeukemiaNet (ELN)." | 7.78 | Assessment and prognostic value of the European LeukemiaNet criteria for clinicohematologic response, resistance, and intolerance to hydroxyurea in polycythemia vera. ( Alvarez-Larrán, A; Angona, A; Arellano-Rodrigo, E; Bellosillo, B; Besses, C; Burgaleta, C; Cervantes, F; Ferrer-Marín, F; Gómez, M; Guillén, H; Hernández-Boluda, JC; Muiña, B; Pereira, A; Teruel, A; Vicente, V, 2012) |
| "Leg ulcers induced by hydroxyurea are rare." | 7.77 | [Hydroxyurea induced-leg ulcer in polycythemia vera]. ( Aissaoui, L; El Guellali, N; Ezzine, N; Fazaa, B; Kamoun, MR; Khaled, A; Robbana, F, 2011) |
| "A 68-year-old women with polycythemia vera was treated with hydroxyurea for 8 years and developed painful ulcers on her lower legs, multiple hypertrophic actinic keratoses and a squamous cell carcinoma." | 7.75 | [Cutaneous side effects of hydroxyurea treatment for polycythemia vera]. ( Akanay-Diesel, S; Hanneken, S; Hoff, NP; Pippirs, U; Schulte, KW, 2009) |
| "The development of painful leg ulcers in the ankle area is a rare and only partially described complication in patients receiving high-dose, long-term hydroxyurea treatment for myeloproliferative diseases." | 7.74 | Hydroxyurea-induced leg ulcers treated with a protease-modulating matrix. ( Dini, V; Romanelli, M; Romanelli, P, 2007) |
| "The efficacy of hydroxyurea (HU) in myeloproliferative disorders is well documented." | 7.73 | Safety profile of hydroxyurea in the treatment of patients with Philadelphia-negative chronic myeloproliferative disorders. ( Fabris, F; Girolami, A; Luzzatto, G; Randi, ML; Ruzzon, E; Tezza, F, 2005) |
| "We report 2 patients with polycythemia vera who were demonstrated to be -negative and were unable to tolerate either hydroxyurea or interferon-alpha but who had excellent clinical responses to imatinib mesylate (STI-571)." | 7.72 | Polycythemia vera responds to imatinib mesylate. ( Dickinson, TM; Jones, CM, 2003) |
| " She had a history of polycythemia vera and had been treated with a daily dose of 500mg hydroxyurea (HU) for six years." | 7.72 | Huge post-operative ulcer following hydroxyurea therapy in a patient with polycythemia vera. ( Iwata, K; Nakano, M; Ogawa, H; Ogura, S; Seki, K; Tasaka, T; Yokota, K, 2003) |
| "Hydroxyurea (HU) is usually a well-tolerated antineoplastic agent, which is commonly used in the treatment of myeloproliferative disorders." | 7.71 | [Hydroxyurea-induced leg ulcers in patients with chronic myeloproliferative disorders]. ( Olesen, LH; Pedersen, BB, 2001) |
| "The leukemogenic risk attributed to therapy of polycythemia vera with radiophosphorus and alkylating drugs has led, over the last 20 years, to the increased use of myelosupressive nonmutagenic drugs, especially hydroxyurea." | 7.71 | Leukemic transformation of polycythemia vera after treatment with hydroxyurea with abnormalities of chromosome 17. ( Fricová, M; Guman, T; Hlebasková, M; Kafková, A; Nebesnáková, E; Raffac, S; Stecová, N; Svorcová, E; Tóthová, E, 2001) |
| "Two prospectively studied patients with polycythemia vera (PV) whose platelet counts showed marked periodic fluctuation during treatment with hydroxyurea (HU) are reported." | 7.70 | Hydroxyurea-induced marked oscillations of platelet counts in patients with polycythemia vera. ( El-Hemaidi, I; Elliott, MA; Kao, PC; Pearson, TC; Tefferi, A; Yoon, S, 2000) |
| "The authors present two patients with polycythemia vera where they recorded after several years' treatment with hydroxyurea development of acute myeloblastic leukaemia." | 7.70 | [Leukemic transformation of polycythemia vera after treatment with hydroxyurea and chromosome 17 abnormalities]. ( Fricová, M; Kafková, A; Nebesnáková, E; Stecová, N; Tóthová, E, 1999) |
| "In polycythemia vera (PV), treatment with chlorambucil and radioactive phosphorus (p32) increases the risk of leukemic transformation from 1% to 13-14%." | 7.69 | Leukemogenic risk of hydroxyurea therapy in polycythemia vera, essential thrombocythemia, and myeloid metaplasia with myelofibrosis. ( Fisher, SG; Godwin, J; Nand, S; Stock, W, 1996) |
| "We report four cases of cutaneous lower leg ulcers associated with hydroxyurea treatment for myeloproliferative disorders." | 7.68 | Hydroxyurea and lower leg ulcers. ( Margolis, DJ; Nguyen, TV, 1993) |
| "From 1963 to 1983, I treated 100 patients with polycythemia vera, using phlebotomy and the adjunctive agent hydroxyurea." | 7.67 | Hydroxyurea in the treatment of polycythemia vera: a prospective study of 100 patients over a 20-year period. ( West, WO, 1987) |
| "Thirty-six patients with polycythemia vera were treated with hydroxyurea for 12 to 67 months." | 7.67 | Treatment of polycythemia vera with hydroxyurea. ( Ben-Arieh, Y; Sharon, R; Tatarsky, I, 1986) |
| "Thrombotic events and disease progression were infrequent in both arms, whereas grade 3/4 adverse events were more frequent with PEG (46% vs 28%)." | 7.11 | A randomized phase 3 trial of interferon-α vs hydroxyurea in polycythemia vera and essential thrombocythemia. ( Arango Ossa, JE; Arcasoy, MO; Bacigalupo, A; Barbui, T; Berenzon, D; Catchatourian, R; De Stefano, V; Dueck, AC; Ewing, J; Farnoud, N; Goldberg, JD; Harrison, CN; Hoffman, R; Kessler, CM; Kiladjian, JJ; Kosiorek, HE; Kremyanskaya, M; Leibowitz, DS; Levine, MF; Marchioli, R; Mascarenhas, J; McGovern, E; McMullin, MF; Mead, AJ; Mesa, RA; Nagler, A; Najfeld, V; O'Connell, CL; Penson, AV; Prchal, JT; Price, L; Rambaldi, A; Rampal, RK; Rondelli, D; Salama, ME; Sandy, L; Silver, RT; Tognoni, G; Tripodi, J; Vannucchi, AM; Weinberg, RS; Winton, EF; Yacoub, A, 2022) |
| "An analysis of the risk of progression towards leukemia, carcinoma and myelofibrosis was performed in 93 patients treated by 32P alone (PVSG protocols) since 1970-1979, 395 patients over the age of 65 years treated by 32P with or without maintenance therapy using hydroxyurea (French protocol) since 1980-1994, and 202 patients under the age of 65 treated by either hydroxyurea or pipobroman since 1980." | 6.18 | Risk of leukaemia, carcinoma, and myelofibrosis in 32P- or chemotherapy-treated patients with polycythaemia vera: a prospective analysis of 682 cases. The "French Cooperative Group for the Study of Polycythaemias". ( Dresch, C; Echard, M; Goguel, A; Grange, MJ; Lejeune, F; Najean, Y; Rain, JD, 1996) |
| "Hydroxyurea (HU) is a standard treatment for high-risk patients with PV." | 5.62 | Differential expression of hydroxyurea transporters in normal and polycythemia vera hematopoietic stem and progenitor cell subpopulations. ( Meier-Abt, F; Tan, G, 2021) |
| "Polycythemia vera is a Philadelphia negative myeloproliferative neoplasm characterized by erythrocytosis in which the major cause of morbidity and mortality is thrombosis." | 5.62 | Management of hydroxyurea resistant or intolerant polycythemia vera. ( Pasricha, SR; Prince, HM; Raman, I; Yannakou, CK, 2021) |
| "Treatment with hydroxyurea resulted in rapid improvement in proteinuria that correlated with a decrease in hematocrit." | 5.43 | Hydroxyurea for Treatment of Nephrotic Syndrome Associated With Polycythemia Vera. ( Chen, YB; Colvin, RB; Hundemer, GL; Rosales, IA; Tolkoff-Rubin, NE, 2016) |
| "Hydroxyurea (HU) treatment of patients with essential thrombocythemia (ET), polycythemia vera (PV), and primary myelofibrosis (PMF) (MPNs) normalizes elevated blood cell counts within weeks in the large majority of patients." | 5.41 | Data-driven analysis of the kinetics of the JAK2V617F allele burden and blood cell counts during hydroxyurea treatment of patients with polycythemia vera, essential thrombocythemia, and primary myelofibrosis. ( Andersen, M; Dam, MJB; Hasselbalch, HC; Kjaer, L; Knudsen, TA; Ottesen, JT; Pedersen, RK; Skov, V, 2021) |
| "At present, the treatment of polycythemia vera (PV) and essential thrombocythemia (ET) is still largely supportive and symptomatic." | 5.39 | Homoharringtonine is an effective therapy for patients with polycythemia vera or essential thrombocythemia who have failed or were intolerant to hydroxycarbamide or interferon-α therapy. ( Ding, B; Li, Y; Zhu, J, 2013) |
| "Twenty-one polycythemia vera, 28 essential thrombocythemia, eight secondary erythrocytosis, and 30 controls were studied." | 5.37 | Differential expression of JAK2 and Src kinase genes in response to hydroxyurea treatment in polycythemia vera and essential thrombocythemia. ( Albizua, E; Ayala, R; Barrio, S; Besses, C; Espinet, B; Florensa, L; Gallardo, M; Jimenez, A; Martinez-Lopez, J; Puigdecanet, E; Rapado, I; Rueda, D; Sanchez-Espiridion, B, 2011) |
| "Hydroxyurea (HU) is a cytotoxic agent, which leads to inactivation of ribonucleotide reductase, inhibition of cellular DNA synthesis, and cell death in the S phase." | 5.34 | Hydroxyurea associated leg ulcer succesfully treated with hyperbaric oxygen in a diabetic patient. ( Akinci, B; Atabey, A; Ilgezdi, S; Yesil, S, 2007) |
| "Polycythemia vera is a very rare disease in childhood; its treatment for this reason is not well established." | 5.29 | [Treatment with hydroxyurea of polycythemia vera in a 11 year-old child]. ( Farriaux, JP; Nelken, B; Vic, P; Vodoff, MV, 1996) |
| "Ruxolitinib, a potent JAK1/JAK2 inhibitor, was found to be superior to the best available therapy (BAT) in controlling hematocrit, reducing splenomegaly, and improving symptoms in the phase 3 RESPONSE study of patients with polycythemia vera with splenomegaly who experienced an inadequate response to or adverse effects from hydroxyurea." | 5.27 | Ruxolitinib is effective and safe in Japanese patients with hydroxyurea-resistant or hydroxyurea-intolerant polycythemia vera with splenomegaly. ( Amagasaki, T; Gadbaw, B; Handa, H; Hino, M; Ito, K; Kirito, K; Miyamura, K; Okamoto, S; Suzuki, K; Takeuchi, M; Yamauchi, K, 2018) |
| "Ruxolitinib was well tolerated and superior to best available therapy (including interferon [IFN]) in controlling hematocrit without phlebotomy eligibility, normalizing blood counts, and improving polycythemia vera-related symptoms in the Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care (RESPONSE) studies." | 5.27 | Efficacy and safety of ruxolitinib after and versus interferon use in the RESPONSE studies. ( Durrant, S; Gadbaw, B; Griesshammer, M; Guglielmelli, P; Jones, M; Khan, M; Kiladjian, JJ; Li, J; Masszi, T; Passamonti, F; Perez Ronco, J; Saydam, G; Verstovsek, S; Zhen, H, 2018) |
| "Hydroxyurea is an effective agent in the treatment of PV, but continued assessment of its mutagenic potential is necessary." | 5.27 | Treatment of polycythemia vera with hydroxyurea. ( Berk, PD; Donovan, PB; Goldberg, JD; Kaplan, ME; Knospe, WH; Laszlo, J; Mack, K; Najean, Y; Silberstein, EB; Tatarsky, I, 1984) |
| "In patients who had an inadequate response to or had unacceptable side effects from hydroxyurea, ruxolitinib was superior to standard therapy in controlling the hematocrit, reducing the spleen volume, and improving symptoms associated with polycythemia vera." | 5.20 | Ruxolitinib versus standard therapy for the treatment of polycythemia vera. ( Durrant, S; Garrett, W; Griesshammer, M; Habr, D; Harrison, CN; He, S; Jones, MM; Kiladjian, JJ; Li, J; Masszi, T; Mesa, R; Pane, F; Passamonti, F; Pirron, U; Vannucchi, AM; Verstovsek, S; Zachee, P, 2015) |
| "Therapeutic options for patients with polycythemia vera (PV) and essential thrombocythemia (ET) resistant or intolerant to hydroxyurea are limited." | 5.19 | Busulfan in patients with polycythemia vera or essential thrombocythemia refractory or intolerant to hydroxyurea. ( Alvarez-Larrán, A; Ancochea, A; Angona, A; Antelo, ML; Bellosillo, B; Besses, C; Burgaleta, C; Cervantes, F; Durán, MA; Ferrer-Marín, F; Gómez, M; Gómez-Casares, MT; Hernández-Boluda, JC; Marcote, B; Martínez-Avilés, L; Martínez-Trillos, A; Mata, MI; Senín, A; Vicente, V; Xicoy, B, 2014) |
| "We randomly assigned 365 adults with JAK2-positive polycythemia vera who were being treated with phlebotomy, hydroxyurea, or both to receive either more intensive treatment (target hematocrit, <45%) (low-hematocrit group) or less intensive treatment (target hematocrit, 45 to 50%) (high-hematocrit group)." | 5.17 | Cardiovascular events and intensity of treatment in polycythemia vera. ( Angelucci, E; Barbui, T; Cacciola, R; Cascavilla, N; Cavazzina, R; Cilloni, D; De Stefano, V; Elli, E; Finazzi, G; Iurlo, A; Latagliata, R; Lunghi, F; Lunghi, M; Marchioli, R; Marfisi, RM; Masciulli, A; Musolino, C; Musto, P; Quarta, G; Randi, ML; Rapezzi, D; Ruggeri, M; Rumi, E; Santini, S; Scarano, M; Scortechini, AR; Siragusa, S; Spadea, A; Specchia, G; Tieghi, A; Vannucchi, AM; Visani, G, 2013) |
| "The overall impact of hydroxyurea (HU) or pipobroman treatments on the long-term outcome of patients with polycythemia vera (PV) has not been assessed in randomized studies." | 5.15 | Treatment of polycythemia vera with hydroxyurea and pipobroman: final results of a randomized trial initiated in 1980. ( Chevret, S; Chomienne, C; Dosquet, C; Kiladjian, JJ; Rain, JD, 2011) |
| " The aims of this study were (1) to detect involvement of N- and K-ras mutations in codons 12 and 13 in the pathogenesis of the chronic and blastic phases of PV and ET, (2) to study the occurrence of microsatellite instability (MSI) in chromosomes 5 and 7 during the chronic phase and blastic transformation of the disease, and (3) to examine the incidence of leukemia in patients treated with hydroxyurea (HU)." | 5.10 | Leukemogenic risk of hydroxyurea therapy as a single agent in polycythemia vera and essential thrombocythemia: N- and K-ras mutations and microsatellite instability in chromosomes 5 and 7 in 69 patients. ( Loukopoulos, D; Madzourani, M; Mavrogianni, D; Meletis, J; Michali, E; Pangalis, G; Terpos, E; Vaiopoulos, G; Viniou, N; Yataganas, X, 2002) |
| "The in vivo effects of hydroxyurea (HU) on circulating erythroid (BFU-E) and granulocyte-macrophage progenitors (CFU-GM) in patients with polycythemia vera (PV) have been evaluated." | 5.08 | Circulating hematopoietic progenitor cells in polycythemia vera: the in vivo effect of hydroxyurea. ( Bogliolo, G; Castello, G; Cavallini, D; Cerruti, A; Lerza, R; Pannacciulli, I, 1995) |
| "Nonradiomimetic drugs, hydroxyurea (HU) and pipobroman (Pi), were administred to relatively young subjects with polycythemia vera (PV) in an attempt to decrease the leukemogenic risk observed in patients treated with 32P." | 5.08 | Treatment of polycythemia vera: the use of hydroxyurea and pipobroman in 292 patients under the age of 65 years. ( Najean, Y; Rain, JD, 1997) |
| "To compare by a prospective study in high risk polycythemia vera (PV) patients 33P alone and 32P followed by low-dose hydroxyurea (HU) maintenance therapy." | 5.08 | [Treatment of polycythemia. I--Using radiophosphorus with or without treatment in 483 patients over 65 years of age]. ( Dupuy, E; Goguel, A; Grange, MJ; Mougeot-Martin, M; Najean, Y; Rain, JD; Vigneron, N, 1998) |
| "To compare by a prospective study in low risk polycythemia vera (PV) patients alone two drugs: hydroxyurea and pipobroman." | 5.08 | [Treatment of polycythemia. II.--Comparison of hydroxyurea with pipobroman in 294 patients less than 65 years of age]. ( Brahimi, S; Echard, M; Fermand, JP; Gruyer, P; Lejeune, F; Najean, Y; Rain, JD, 1998) |
| "Between 1980 and 1991, 96 patients with documented polycythemia vera were treated by hydroxyurea or pipobroman, according to a protocol including randomization, and maintenance therapy." | 5.07 | [Treatment of polycythemia vera with hydroxyurea or pipobroman. Efficacy and toxicity analysed from a protocol of 96 patients under 65 years of age. Le Groupe d'Etude des Polyglobulies]. ( Najean, Y, 1992) |
| " It is the first interferon approved for the treatment of patients with polycythemia vera (PV) and the first and only approved treatment for PV independent of previous hydroxyurea exposure." | 5.05 | Ropeginterferon alfa-2b for the treatment of patients with polycythemia vera. ( Greil, R; Melchardt, T; Wagner, SM, 2020) |
| "Hydroxyurea is the standard treatment in high-risk patients with polycythemia vera." | 5.01 | Clinical outcomes under hydroxyurea treatment in polycythemia vera: a systematic review and meta-analysis. ( Barbui, T; Carobbio, A; De Stefano, V; Ferrari, A; Finazzi, G; Ghirardi, A; Masciulli, A; Vannucchi, AM, 2019) |
| "Hydroxyurea (HU) has traditionally been the first-line treatment for patients with polycythemia vera (PV) or essential thrombocythemia (ET) at high risk for vascular complications." | 4.90 | Therapeutic options for patients with polycythemia vera and essential thrombocythemia refractory/resistant to hydroxyurea. ( Newberry, KJ; Sever, M; Verstovsek, S, 2014) |
| "In the past, management of polycythemia vera (PV) was built upon a cornerstone of control over erythrocytosis, through therapeutic phlebotomy, as well as the use of low-dose aspirin." | 4.89 | Polycythemia vera: current pharmacotherapy and future directions. ( Geyer, H; Hensley, B; Mesa, R, 2013) |
| " An algorithm for the treatment of patients with erythremia is proposed along with recommendations on the use of aspirin, hydroxyurea, alpha-interpheron, and imatinib." | 4.88 | [True polycythemia: current views of pathogenesis, diagnostics and treatment]. ( Bakhteeva, TD; Kalinkina, NV; Skliannaia, EV; Taradin, GG; Vatutin, NT, 2012) |
| "Hydroxyurea is an old drug that is often used to control essential thrombocythemia and polycythemia vera in patients with high-risk disease." | 4.83 | Hydroxyurea: The drug of choice for polycythemia vera and essential thrombocythemia. ( Dingli, D; Tefferi, A, 2006) |
| "Hydroxyurea (HU) is effective in controlling thrombocytosis while reducing the risk of thrombosis in essential thrombocythemia (ET), polycythemia vera (PV) and myelofibrosis (MF)." | 4.83 | Leg ulcers in elderly on hydroxyurea: a single center experience in Ph- myeloproliferative disorders and review of literature. ( Fabris, F; Luzzatto, G; Randi, ML; Ruzzon, E; Scandellari, R; Tezza, F, 2006) |
| "Hydroxyurea (HU) is commonly used for the treatment of chronic myelogenous leukaemia, polycythemia vera and essential thrombocythaemia." | 4.82 | Oral squamous cell carcinoma during long-term treatment with hydroxyurea. ( De Benedittis, M; Favia, G; Giardina, C; Lo Muzio, L; Petruzzi, M; Serpico, R, 2004) |
| "Retrospective, descriptive study of the medical records of patients who developed leg ulcers while receiving hydroxyurea therapy." | 4.80 | Hydroxyurea-induced leg ulceration in 14 patients. ( Best, PJ; Daoud, MS; Petitt, RM; Pittelkow, MR, 1998) |
| " Randomized studies have shown that the risk of thrombosis was significantly reduced in ET with the use of hydroxyurea (HU) and in PV with the use of chlorambucil or 32P." | 4.80 | Treatment of polycythaemia vera and essential thrombocythaemia. ( Silverstein, MN; Tefferi, A, 1998) |
| " Treatment selection is based on a patient's age and a history of thrombosis in patients with low-risk PV treated with therapeutic phlebotomy and aspirin alone, whereas cytoreductive therapy with either hydroxyurea or interferon alfa (IFN-α) is added for high-risk disease." | 4.31 | Moving toward disease modification in polycythemia vera. ( Bewersdorf, JP; Bose, P; How, J; Masarova, L; Mascarenhas, J; Pemmaraju, N; Rampal, RK, 2023) |
| "Ruxolitinib is approved for patients with polycythemia vera (PV) who are resistant/intolerant to hydroxyurea, but its impact on preventing thrombosis or disease-progression is unknown." | 4.12 | Real-world analysis of main clinical outcomes in patients with polycythemia vera treated with ruxolitinib or best available therapy after developing resistance/intolerance to hydroxyurea. ( Alvarez-Larrán, A; Angona, A; Arellano-Rodrigo, E; Ayala, R; Bellosillo, B; Caballero, G; Carreño-Tarragona, G; Cuevas, B; Del Orbe-Barreto, R; Ferrer-Marín, F; Fox, ML; García, R; García-Gutiérrez, V; García-Hernández, C; Garrote, M; Gasior, M; Gómez, M; Gómez-Casares, MT; Guerrero, L; Hernández-Boluda, JC; Magro, E; Martínez, CM; Mata-Vazquez, MI; Murillo, I; Pereira, A; Pérez-Encinas, M; Pérez-López, R; Ramírez, MJ; Raya, JM; Xicoy, B, 2022) |
| "To determine the prevalence, clinical outcomes, and factors associated with hydroxyurea (HU) resistance or intolerance among polycythemia vera (PV) and essential thrombocythemia (ET) patients." | 4.12 | Prevalence and clinical outcomes of polycythemia vera and essential thrombocythemia with hydroxyurea resistance or intolerance. ( Chai-Adisaksopha, C; Chiaranairungrot, K; Hantrakool, S; Kaewpreechawat, K; Norasetthada, L; Pagowong, N; Piriyakhuntorn, P; Rattanathammethee, T; Rattarittamrong, E; Sajai, C; Sukarat, N; Tantiworawit, A, 2022) |
| "Hydroxyurea is a chemotherapeutic agent used for myeloproliferative disorders and sickle cell anemia that is well known to cause painful mucocutaneous ulcers, typically involving the legs or mouth." | 4.02 | Hydroxyurea-induced genital ulcers and erosions: Two case reports. ( Blum, AE; Kemp, JM; Tsiaras, WG, 2021) |
| "Approximately one-quarter of patients with polycythemia vera become resistant to and/or intolerant of hydroxyurea." | 4.02 | Real-World Dosing Patterns of Ruxolitinib in Patients With Polycythemia Vera Who Are Resistant to or Intolerant of Hydroxyurea. ( Altomare, I; Colucci, P; Kish, J; Lord, K; Paranagama, D; Parasuraman, S; Yu, J, 2021) |
| "This study aimed to evaluate real-life data on patterns of hydroxyurea prescription/use in polycythemia vera (PV)." | 3.96 | Patterns of Hydroxyurea Prescription and Use in Routine Clinical Management of Polycythemia Vera: A Multicenter Chart Review Study ( Ali, R; Altuntaş, F; Ar, MC; Ayyıldız, O; Büyükaşık, Y; Çiftçiler, R; Gökçen, E; Güven, Z; Karakuş, A; Mastanzade, M; Meletli, Ö; Okay, M; Saydam, G; Soyer, N; Soysal, T; Tuğlular, T; Turgut, M; Uçar, B; Ünal, A; Yavuz, AS; Yiğenoğlu, TN, 2020) |
| "Hydroxyurea (HU) resistance or intolerance occurs in 15 to 24% of patients with polycythemia vera (PV)." | 3.91 | Polycythemia vera and hydroxyurea resistance/intolerance: a monocentric retrospective analysis. ( Delforge, M; Demuynck, T; Devos, T; Vandenberghe, P; Verhoef, G, 2019) |
| "Bone marrow suppression medications (oral hydroxyurea and subcutaneous injection of interferon) were given and subsequent prevention of cerebral infarction was implemented." | 3.88 | A case report of cerebral infarction caused by polycythemia vera. ( Chen, Z; Gao, F; Ren, S; Wang, Z, 2018) |
| "A 65-year-old man was diagnosed with polycythemia vera (PV) and treated with hydroxyurea." | 3.85 | Pulmonary Hypertension Associated with Pulmonary Veno-occlusive Disease in Patients with Polycythemia Vera. ( Matsumura, A; Miyazaki, T; Nakajima, H; Nakajima, Y; Nakayama, N; Tachibana, T; Takahashi, H, 2017) |
| "Pegylated interferon (peg-IFN) was proven by phase II trials to be effective in polycythemia vera (PV); however, it is not clear whether it could improve patient outcome compared to hydroxyurea (HU)." | 3.85 | Can pegylated interferon improve the outcome of polycythemia vera patients? ( Beggiato, E; Benevolo, G; Boccadoro, M; Borchiellini, A; Cerrano, M; Crisà, E; Ferrero, D; Lanzarone, G; Manzini, PM; Riera, L, 2017) |
| " Post-2005 diagnosed patients were also more or less likely to receive aspirin and cytoreductive therapy, respectively, and, despite their older age distribution, displayed significantly lower risk of thrombosis in high risk disease." | 3.81 | Patterns of presentation and thrombosis outcome in patients with polycythemia vera strictly defined by WHO-criteria and stratified by calendar period of diagnosis. ( Barbui, T; Carobbio, A; Finazzi, G; Gisslinger, H; Pardanani, A; Passamonti, F; Pieri, L; Rambaldi, A; Randi, ML; Rodeghiero, F; Rumi, E; Tefferi, A; Thiele, J; Vannucchi, AM, 2015) |
| "Patients in the interferon alpha 2 b group achieved higher rates of hematologic and molecular remission than patients in the hydroxyurea group, with a lower incidence of thrombosis." | 3.80 | Interferon apha 2b for treating patients with JAK2V617F positive polycythemia vera and essential thrombocytosis. ( Duan, YC; Zhang, ZR, 2014) |
| "This study was designed to compare the oxidative stress parameters of patients with polycythemia vera (PV) to those of healthy volunteers and to investigate the probable relationship between vascular events and parameters of oxidative status such as total oxidative status (TOS), total antioxidant status, oxidative stress index (OSI) and malondialdehyde (MDA) in PV patients." | 3.80 | The thrombotic events in polycythemia vera patients may be related to increased oxidative stress. ( Akalin, I; Alver, A; Durmus, A; Mentese, A; Sumer, A; Topal, C; Yilmaz, M, 2014) |
| "Hydroxyurea (HU) has been shown to induce a variety of cutaneous adverse reactions, including severe leg ulcers." | 3.78 | A multidisciplinary team approach to hydroxyurea-associated chronic wound with squamous cell carcinoma. ( Berger, A; Blumberg, S; Chen, W; McMeeking, A; O'Neill, D; Pastar, I; Ross, F; Stone, T, 2012) |
| "Criteria of response and definition of resistance and intolerance to hydroxyurea (HU) in polycythemia vera (PV) were proposed by the European LeukemiaNet (ELN)." | 3.78 | Assessment and prognostic value of the European LeukemiaNet criteria for clinicohematologic response, resistance, and intolerance to hydroxyurea in polycythemia vera. ( Alvarez-Larrán, A; Angona, A; Arellano-Rodrigo, E; Bellosillo, B; Besses, C; Burgaleta, C; Cervantes, F; Ferrer-Marín, F; Gómez, M; Guillén, H; Hernández-Boluda, JC; Muiña, B; Pereira, A; Teruel, A; Vicente, V, 2012) |
| "Leg ulcers induced by hydroxyurea are rare." | 3.77 | [Hydroxyurea induced-leg ulcer in polycythemia vera]. ( Aissaoui, L; El Guellali, N; Ezzine, N; Fazaa, B; Kamoun, MR; Khaled, A; Robbana, F, 2011) |
| " The patient was on long-term therapy with hydroxyurea (HU) for polycythemia vera." | 3.77 | Concurrent basal cell and squamous cell carcinomas associated with hydroxyurea therapy. ( Batinac, T; Hadžisejdić, I; Jonjić, N; Načinović-Duletić, A; Radić, J; Valković, T, 2011) |
| " Prior to admission to our hospital for nephrotic syndrome, she had received hydroxyurea and phlebotomy." | 3.76 | Histopathological manifestations of membranoproliferative glomerulonephritis and glomerular expression of plasmalemmal vesicle-associated protein-1 in a patient with polycythemia vera. ( Kashihara, N; Kozuka, Y; Nagasu, H; Nakanishi, H; Namikoshi, T; Nishi, Y; Sasaki, T; Tokura, T, 2010) |
| "A 68-year-old women with polycythemia vera was treated with hydroxyurea for 8 years and developed painful ulcers on her lower legs, multiple hypertrophic actinic keratoses and a squamous cell carcinoma." | 3.75 | [Cutaneous side effects of hydroxyurea treatment for polycythemia vera]. ( Akanay-Diesel, S; Hanneken, S; Hoff, NP; Pippirs, U; Schulte, KW, 2009) |
| "We analyzed the effect of hydroxyurea on the JAK2V617F allelic ratio (%JAK2V617F), measured in purified blood granulocytes, of patients with polycythemia vera and essential thrombocythemia." | 3.74 | Frequent reduction or absence of detection of the JAK2-mutated clone in JAK2V617F-positive patients within the first years of hydroxyurea therapy. ( Cleyrat, C; Duval, A; Girodon, F; Hermouet, S; Lafont, I; Maynadié, M; Mounier, M; Santos, FD; Schaeffer, C; Vidal, A, 2008) |
| "The development of painful leg ulcers in the ankle area is a rare and only partially described complication in patients receiving high-dose, long-term hydroxyurea treatment for myeloproliferative diseases." | 3.74 | Hydroxyurea-induced leg ulcers treated with a protease-modulating matrix. ( Dini, V; Romanelli, M; Romanelli, P, 2007) |
| "Hydroxyurea (HU) is a ribonucleotide reductase inhibitor used to treat myeloproliferative diseases including polycythemia vera (PV) and essential thrombocythemia (ET)." | 3.74 | Hydroxyurea induced acute elevations in liver function tests. ( Hallam, MJ; Kolesar, JM, 2008) |
| "We report three male patients, with duplex confirmed chronic venous disease, who were on treatment with hydroxyurea for chronic myelogenous leukaemia (CML) and polycythemia vera (PV), referred to us for the management of non-healing perimalleolar ulcers of varying durations." | 3.73 | Perimalleolar ulcers in hydroxyurea treated patients with concomitant chronic venous disease: diagnostic pitfalls. ( Gupta, K; Jain, V; Nagpal, N, 2005) |
| "The efficacy of hydroxyurea (HU) in myeloproliferative disorders is well documented." | 3.73 | Safety profile of hydroxyurea in the treatment of patients with Philadelphia-negative chronic myeloproliferative disorders. ( Fabris, F; Girolami, A; Luzzatto, G; Randi, ML; Ruzzon, E; Tezza, F, 2005) |
| "A 77-year-old female with polycythemia vera (PV) showed a sudden, typical chronic myeloid leukaemia (CML), 8 yr after the initial diagnosis, and an intermittent treatment with hydroxyurea (0." | 3.73 | Transition of polycythemia vera to chronic myeloid leukaemia. ( Emilia, G; Ferrara, L; Fiorani, C; Longo, G; Mazzocchi, V; Saviola, A; Temperani, P; Torelli, G; Zucchini, P, 2005) |
| "Patients with polycythemia vera (PV) are most often treated with phlebotomy-only (PHL-O) or phlebotomy plus hydroxyurea (PHL + HU)." | 3.73 | Long-term effects of the treatment of polycythemia vera with recombinant interferon-alpha. ( Silver, RT, 2006) |
| "We report 2 patients with polycythemia vera who were demonstrated to be -negative and were unable to tolerate either hydroxyurea or interferon-alpha but who had excellent clinical responses to imatinib mesylate (STI-571)." | 3.72 | Polycythemia vera responds to imatinib mesylate. ( Dickinson, TM; Jones, CM, 2003) |
| " She had a history of polycythemia vera and had been treated with a daily dose of 500mg hydroxyurea (HU) for six years." | 3.72 | Huge post-operative ulcer following hydroxyurea therapy in a patient with polycythemia vera. ( Iwata, K; Nakano, M; Ogawa, H; Ogura, S; Seki, K; Tasaka, T; Yokota, K, 2003) |
| "Hydroxyurea (HU) is usually a well-tolerated antineoplastic agent, which is commonly used in the treatment of myeloproliferative disorders." | 3.71 | [Hydroxyurea-induced leg ulcers in patients with chronic myeloproliferative disorders]. ( Olesen, LH; Pedersen, BB, 2001) |
| "The leukemogenic risk attributed to therapy of polycythemia vera with radiophosphorus and alkylating drugs has led, over the last 20 years, to the increased use of myelosupressive nonmutagenic drugs, especially hydroxyurea." | 3.71 | Leukemic transformation of polycythemia vera after treatment with hydroxyurea with abnormalities of chromosome 17. ( Fricová, M; Guman, T; Hlebasková, M; Kafková, A; Nebesnáková, E; Raffac, S; Stecová, N; Svorcová, E; Tóthová, E, 2001) |
| " The study group comprised hydroxyurea treated and untreated patients with essential thrombocytosis (ET) or polycythemia vera (PV)." | 3.71 | Replication status in leukocytes of treated and untreated patients with polycythemia vera and essential thrombocytosis. ( Amiel, A; Elis, A; Ellis, M; Fejgin, MD; Gaber, E; Herishano, Y; Lishner, M; Maimon, O, 2002) |
| "Two prospectively studied patients with polycythemia vera (PV) whose platelet counts showed marked periodic fluctuation during treatment with hydroxyurea (HU) are reported." | 3.70 | Hydroxyurea-induced marked oscillations of platelet counts in patients with polycythemia vera. ( El-Hemaidi, I; Elliott, MA; Kao, PC; Pearson, TC; Tefferi, A; Yoon, S, 2000) |
| "The authors present two patients with polycythemia vera where they recorded after several years' treatment with hydroxyurea development of acute myeloblastic leukaemia." | 3.70 | [Leukemic transformation of polycythemia vera after treatment with hydroxyurea and chromosome 17 abnormalities]. ( Fricová, M; Kafková, A; Nebesnáková, E; Stecová, N; Tóthová, E, 1999) |
| "Three patients are described with late-stage myeloproliferative diseases, two with accelerated phase chronic myelogenous leukemia (CML) and one with refractory polycythemia vera (P vera), who achieved hematologic control after the addition of interferon (IFN) to hydroxyurea therapy." | 3.69 | Efficacy of alpha interferon and hydroxyurea in late phase refractory myeloproliferative disease. ( Landaw, SA; Litam, PP; Zamkoff, KW, 1994) |
| "In polycythemia vera (PV), treatment with chlorambucil and radioactive phosphorus (p32) increases the risk of leukemic transformation from 1% to 13-14%." | 3.69 | Leukemogenic risk of hydroxyurea therapy in polycythemia vera, essential thrombocythemia, and myeloid metaplasia with myelofibrosis. ( Fisher, SG; Godwin, J; Nand, S; Stock, W, 1996) |
| "We report four cases of cutaneous lower leg ulcers associated with hydroxyurea treatment for myeloproliferative disorders." | 3.68 | Hydroxyurea and lower leg ulcers. ( Margolis, DJ; Nguyen, TV, 1993) |
| " We examined Hb F in 13 patients with myeloproliferative disease (six polycythemia vera, five polycythemia vera with myeloid metaplasia, one agnogenic myeloid metaplasia, and one chronic myelogenous leukemia) who were treated with hydroxyurea." | 3.67 | The effect of hydroxyurea on hemoglobin F in patients with myeloproliferative syndromes. ( Alter, BP; Gilbert, HS, 1985) |
| "From 1963 to 1983, I treated 100 patients with polycythemia vera, using phlebotomy and the adjunctive agent hydroxyurea." | 3.67 | Hydroxyurea in the treatment of polycythemia vera: a prospective study of 100 patients over a 20-year period. ( West, WO, 1987) |
| "Thirty-six patients with polycythemia vera were treated with hydroxyurea for 12 to 67 months." | 3.67 | Treatment of polycythemia vera with hydroxyurea. ( Ben-Arieh, Y; Sharon, R; Tatarsky, I, 1986) |
| " One hundred nine adverse events (AEs) occurred in 24/28 patients (all grade 1 to 3), and no pt permanently discontinued treatment because of AEs." | 3.30 | Efficacy and safety of ruxolitinib in patients with newly-diagnosed polycythemia vera: futility analysis of the RuxoBEAT clinical trial of the GSG-MPN study group. ( Brümmendorf, TH; Crysandt, M; Döhner, K; Frank, J; Franklin, J; Gezer, D; Griesshammer, M; Heidel, FH; Hellmich, M; Hochhaus, A; Isfort, S; Jost, PJ; Kortmann, M; Koschmieder, S; Maurer, A; Parmentier, S; Platzbecker, U; Schafhausen, P; Schaich, M; Stegelmann, F; von Bubnoff, N; Wolf, D; Wolleschak, D, 2023) |
| " This study assesses the safety, efficacy and molecular response of ropeginterferon α-2b in Chinese patients with PV utilizing the 250-350-500 μg dosing schema." | 3.30 | A phase II trial to assess the efficacy and safety of ropeginterferon α-2b in Chinese patients with polycythemia vera. ( Jin, J; Li, Y; Qin, A; Shen, W; Wang, W; Wu, D; Xiao, Z; Zhang, J; Zhang, L, 2023) |
| " Overall, the idasanutlin dosing regimen showed clinical activity and rapidly reduced JAK2 allele burden in patients with HU-resistant/- intolerant PV but was associated with low-grade gastrointestinal toxicity, leading to poor long-term tolerability." | 3.11 | The MDM2 antagonist idasanutlin in patients with polycythemia vera: results from a single-arm phase 2 study. ( Bellini, M; Burbury, K; El-Galaly, TC; Gerds, A; Gupta, V; Higgins, B; Huw, LY; Jamois, C; Katakam, S; Kovic, B; Maffioli, M; Mascarenhas, J; Mesa, R; Palmer, J; Passamonti, F; Ross, DM; Vannucchi, AM; Wonde, K; Yacoub, A, 2022) |
| "Thrombotic events and disease progression were infrequent in both arms, whereas grade 3/4 adverse events were more frequent with PEG (46% vs 28%)." | 3.11 | A randomized phase 3 trial of interferon-α vs hydroxyurea in polycythemia vera and essential thrombocythemia. ( Arango Ossa, JE; Arcasoy, MO; Bacigalupo, A; Barbui, T; Berenzon, D; Catchatourian, R; De Stefano, V; Dueck, AC; Ewing, J; Farnoud, N; Goldberg, JD; Harrison, CN; Hoffman, R; Kessler, CM; Kiladjian, JJ; Kosiorek, HE; Kremyanskaya, M; Leibowitz, DS; Levine, MF; Marchioli, R; Mascarenhas, J; McGovern, E; McMullin, MF; Mead, AJ; Mesa, RA; Nagler, A; Najfeld, V; O'Connell, CL; Penson, AV; Prchal, JT; Price, L; Rambaldi, A; Rampal, RK; Rondelli, D; Salama, ME; Sandy, L; Silver, RT; Tognoni, G; Tripodi, J; Vannucchi, AM; Weinberg, RS; Winton, EF; Yacoub, A, 2022) |
| " Anaemia was the most common adverse event in patients receiving ruxolitinib (rates per 100 patient-years of exposure were 8·9 for ruxolitinib and 8·8 for the crossover population), though most anaemia events were mild to moderate in severity (grade 1 or 2 anaemia rates per 100 patient-years of exposure were 8·0 for ruxolitinib and 8·2 for the crossover population)." | 2.94 | Long-term efficacy and safety of ruxolitinib versus best available therapy in polycythaemia vera (RESPONSE): 5-year follow up of a phase 3 study. ( Besses, C; Blau, IW; Dong, T; Durrant, S; Francillard, N; Griesshammer, M; Harrison, CN; Hino, M; Kiladjian, JJ; Kirito, K; Masszi, T; Mesa, R; Miller, CB; Moiraghi, B; Pane, F; Passamonti, F; Rosti, V; Rumi, E; Vannucchi, AM; Verstovsek, S; Wroclawska, M; Zachee, P, 2020) |
| " Adverse events were primarily grades 1/2 with no unexpected safety signals." | 2.84 | The efficacy and safety of continued hydroxycarbamide therapy versus switching to ruxolitinib in patients with polycythaemia vera: a randomized, double-blind, double-dummy, symptom study (RELIEF). ( Byrne, J; Garg, M; Habr, D; Hasan, Y; Hunter, D; Jones, MM; Koschmieder, S; Lyons, R; Martino, B; Mesa, R; Passamonti, F; Rinaldi, C; Vannucchi, AM; Verstovsek, S; Yacoub, A; Zachee, P; Zhen, H, 2017) |
| " In this multicentre, open-label, phase II study, 44 patients with polycythaemia vera (PV), unresponsive to the maximum tolerated doses (MTD) of hydroxycarbamide (HC), were treated with Givinostat (50 or 100 mg/d) in combination with MTD of HC." | 2.78 | A phase II study of Givinostat in combination with hydroxycarbamide in patients with polycythaemia vera unresponsive to hydroxycarbamide monotherapy. ( Barbui, T; Barosi, G; Cilloni, D; Demuth, T; Finazzi, G; Finazzi, MC; Fioritoni, G; Martinelli, V; Musolino, C; Nobile, F; Olimpieri, OM; Pogliani, EM; Rambaldi, A; Ruggeri, M; Sivera, P; Specchia, G; Tollo, SD; Vannucchi, AM, 2013) |
| "Polycythemia vera is one of three stem-cell-derived myeloid malignancies commonly known as myeloproliferative neoplasms." | 2.72 | Polycythemia Vera: Rapid Evidence Review. ( Fox, S; Griffin, L; Robinson Harris, D, 2021) |
| "Current treatment for polycythemia vera (PV) is limited and primarily targets thrombosis risk." | 2.66 | Novel agents for the treatment of polycythemia vera: an insight into preclinical research and early phase clinical trials. ( Mesa, R; Padrnos, L, 2020) |
| "Nonmelanoma skin cancer is the most common malignant tumor in the fair skin population, with each year several millions of diagnosed cases." | 2.61 | Nonmelanoma skin cancer associated with Hydroxyurea treatment: Overview of the literature and our own experience. ( Cantisani, C; Cantoresi, F; Carmosino, I; Cartoni, C; Kiss, N; Naqeshbandi, AF; Tofani, S; Tosti, G, 2019) |
| "Polycythemia vera (PV) and essential thrombocythemia (ET) are myeloproliferative neoplasms, respectively characterized by erythrocytosis and thrombocytosis." | 2.52 | Polycythemia vera and essential thrombocythemia: 2015 update on diagnosis, risk-stratification and management. ( Barbui, T; Tefferi, A, 2015) |
| "Treatment with busulfan or interferon-α is usually effective in hydroxyurea failures." | 2.48 | Polycythemia vera and essential thrombocythemia: 2012 update on diagnosis, risk stratification, and management. ( Tefferi, A, 2012) |
| "Hydroxyurea (HU) has a limited, if any, leukemogenic potential and should be considered the current cytotoxic drug for patients at high risk for thrombotic complications, ie, those with age above 60 years or previous thrombotic events." | 2.42 | The leukemia controversy in myeloproliferative disorders: is it a natural progression of disease, a secondary sequela of therapy, or a combination of both? ( Barbui, T, 2004) |
| "Its use in the treatment of essential thrombocythemia began later in 1950." | 2.41 | Treatment of the myeloproliferative disorders with 32P. ( Berlin, NI, 2000) |
| "Venous thrombosis is more frequent in PV than in ET; superficial or deep venous thromboses are seen." | 2.41 | [What vascular events suggest a myeloproliferative disorder?]. ( Caulier-Leleu, MT; Hachulla, E; Pasturel-Michon, U; Rose, C; Trillot, N, 2000) |
| "Phlebotomy is the mainstay of treatment for polycythemia vera." | 2.41 | Diagnosis and treatment of thrombocythemia in myeloproliferative disorders. ( Gilbert, HS, 2001) |
| "The principal risks of essential thrombocythemia include thrombosis, major hemorrhage, and conversion to leukemia or myelofibrosis." | 2.41 | Therapeutic options for essential thrombocythemia and polycythemia vera. ( Solberg, LA, 2002) |
| "Busulfan was temporally effective in controlling the neutrophil count." | 2.40 | Transition of polycythemia vera to chronic neutrophilic leukemia. ( Endo, M; Fujita, K; Harada, H; Higuchi, T; Mori, H; Niikura, H; Oba, R; Omine, M, 1999) |
| "Hydroxyurea (HU) is a guideline-recommended cytoreductive therapy for patients at high risk for MPNs." | 1.91 | Second malignancies among older patients with classical myeloproliferative neoplasms treated with hydroxyurea. ( Gore, SD; Huntington, SF; Ma, X; Podoltsev, NA; Shallis, RM; Stempel, JM; Wang, R; Zeidan, AM, 2023) |
| " Treatment with IFN gradually lowers elevated cell counts within weeks and when the dosage is reduced, the cell counts do not rapidly increase but are sustained within the normal range in the large majority of patients." | 1.91 | A novel integrated biomarker index for the assessment of hematological responses in MPNs during treatment with hydroxyurea and interferon-alpha2. ( Andersen, M; Dam, MJB; Ellervik, C; Hasselbalch, HC; Kjaer, L; Knudsen, TA; Larsen, MK; Ottesen, JT; Pedersen, RK; Skov, V, 2023) |
| "Chronic inflammation is believed to play an important role in the development and disease progression of polycythemia vera (PV)." | 1.91 | The gut microbiota in patients with polycythemia vera is distinct from that of healthy controls and varies by treatment. ( Andersen, LO; Christensen, JJE; Christensen, SF; Eickhardt-Dalbøge, CS; Ellervik, C; Fuursted, K; Hasselbalch, HC; Ingham, AC; Kjær, L; Knudsen, TA; Larsen, MK; Nielsen, HV; Nielsen, XC; Olsen, LR; Skov, V; Stensvold, CR, 2023) |
| "Pruritus is a frequent symptom experienced by patients with myeloproliferative neoplasms (MPN)." | 1.91 | Differences between aquagenic and non-aquagenic pruritus in myeloproliferative neoplasms: An observational study of 500 patients. ( Ficheux, AS; Herbreteau, L; Ianotto, JC; Le Gall-Ianotto, C; Lippert, E; Misery, L; Pan-Petesch, B; Rio, L, 2023) |
| "Primary myelofibrosis (PM) is one of the myeloproliferative neoplasm, where stem cell-derived clonal neoplasms was noticed." | 1.91 | Detection of primary myelofibrosis in blood serum via Raman spectroscopy assisted by machine learning approaches; correlation with clinical diagnosis. ( Aday, A; Bayrak, AG; Ceylan, Z; Depciuch, J; Guleken, Z; Hindilerden, İY; Jakubczyk, D; Jakubczyk, P; Kula-Maximenko, M; Nalçacı, M, 2023) |
| "Hydroxyurea was the most frequently used drug followed by ruxolitinib, while interferons were reported for a minority of patients." | 1.72 | Cytoreductive treatment in real life: a chart review analysis on 1440 patients with polycythemia vera. ( Crodel, CC; Heidel, FH; Jacobasch, L; Jentsch-Ullrich, K; Palandri, F; Reiser, M; Sauer, A; Tesch, H; Ulshöfer, T; Wunschel, R, 2022) |
| "Within the 1258 SMF of the MYSEC (MYelofibrosis SECondary to PV and ET) dataset, 135 (10." | 1.72 | Prediction of thrombosis in post-polycythemia vera and post-essential thrombocythemia myelofibrosis: a study on 1258 patients. ( Albano, F; Arcaini, L; Auteri, G; Barbui, T; Benevolo, G; Bertù, L; Brociner, M; Caramazza, D; Caramella, M; Casetti, IC; Cattaneo, D; Cervantes, F; De Stefano, V; Della Porta, MG; Devos, T; Gotlib, J; Guglielmelli, P; Iurlo, A; Kiladjian, JJ; Komrokji, RS; Kuykendall, A; Maffioli, M; Merli, M; Mora, B; Palandri, F; Passamonti, F; Ross, DM; Rotunno, G; Ruggeri, M; Rumi, E; Salmoiraghi, S; Silver, RT; Vannucchi, AM, 2022) |
| "Hydroxyurea (HU) is a standard treatment for high-risk patients with PV." | 1.62 | Differential expression of hydroxyurea transporters in normal and polycythemia vera hematopoietic stem and progenitor cell subpopulations. ( Meier-Abt, F; Tan, G, 2021) |
| "Polycythemia vera is a Philadelphia negative myeloproliferative neoplasm characterized by erythrocytosis in which the major cause of morbidity and mortality is thrombosis." | 1.62 | Management of hydroxyurea resistant or intolerant polycythemia vera. ( Pasricha, SR; Prince, HM; Raman, I; Yannakou, CK, 2021) |
| "Risk of thrombosis is higher in JAK2-mutated ET." | 1.51 | Polycythemia vera and essential thrombocythemia: 2019 update on diagnosis, risk-stratification and management. ( Barbui, T; Tefferi, A, 2019) |
| "Polycythemia vera is a chronic myeloproliferative neoplasm, which is primarily characterized by elevated erythrocyte count with the risk of thrombosis, hemorrhage, and vasomotor symptoms." | 1.51 | Cerebral Hemorrhage of a 50-Year-Old Female Patient with Polycythemia Vera. ( Chen, L; Hu, Z; Xiao, H, 2019) |
| "Cases (n = 647) were patients with second cancer (SC: carcinoma, non-melanoma skin cancer, hematological second cancer, and melanoma) and controls (n = 1234) were patients without SC, matched with cases for sex, age at MPN diagnosis, date of MPN diagnosis, and MPN disease duration." | 1.51 | Second cancer in Philadelphia negative myeloproliferative neoplasms (MPN-K). A nested case-control study. ( Alvarez-Larran, A; Angona, A; Barbui, T; Beggiato, E; Benevolo, G; Bertolotti, L; Betti, S; Bonifacio, M; Cacciola, R; Carli, G; Carobbio, A; Casetti, IC; Cattaneo, D; De Stefano, V; Delaini, F; Di Veroli, A; Elli, EM; Erez, D; Finazzi, G; Fox, ML; Ghirardi, A; Gomez, M; Griesshammer, M; Guglielmelli, P; Iurlo, A; Lunghi, F; Marchetti, M; Masciulli, A; McMullin, MF; Palandri, F; Palova, M; Patriarca, A; Perez-Encinas, M; Recasens, V; Rumi, E; Scaffidi, L; Stephenson, C; Tieghi, A; Vannucchi, AM; Vianelli, N; Wille, K, 2019) |
| "Polycythemia vera is a chronic myeloproliferative neoplasm characterized by the JAK2V617F mutation, elevated blood cell counts and a high risk of thrombosis." | 1.48 | Impact of hydroxycarbamide and interferon-α on red cell adhesion and membrane protein expression in polycythemia vera. ( Bigot, S; Brusson, M; Cassinat, B; Chomienne, C; Cochet, S; De Grandis, M; El Nemer, W; Guillonneau, F; Kiladjian, JJ; Le Van Kim, C; Leduc, M; Marin, M; Mayeux, P; Peyrard, T, 2018) |
| "However, chorea is a rare complication of this disease, occurring in less than 5% of the patients." | 1.48 | Sudden hemichorea and frontal lobe syndrome: a rare presentation of unbalanced polycythaemia vera. ( Fernandez-Dominguez, J; García-Cabo, C; Mateos, V, 2018) |
| "Hydroxyurea is an antimetabolite primarily used to treat myeloproliferative disorders, and chronic treatment is associated with many cutaneous adverse effects ranging in severity from ichthyosis to aggressive nonmelanoma skin cancer." | 1.46 | A patient case highlighting the myriad of cutaneous adverse effects of prolonged use of hydroxyurea. ( Aires, D; Neill, B; Neill, J; Rajpara, A; Ryser, T, 2017) |
| "Hydroxyurea was the most commonly used cytoreductive therapy." | 1.46 | Multicenter Retrospective Analysis of Turkish Patients with Chronic Myeloproliferative Neoplasms. ( Bilgir, O; Çağlıyan, G; Çekdemir, D; Cömert, M; Haznedaroğlu, İC; İlhan, O; Kaya, E; Özdemirkıran, F; Şahin, F; Saydam, G; Soyer, N; Ünal, A; Vural, F; Yılmaz, M, 2017) |
| "Polycythemia Vera (PV) and essential thrombocythemia (ET) are myeloproliferative neoplasms respectively characterized by erythrocytosis and thrombocytosis; other disease features include leukocytosis, splenomegaly, thrombosis, bleeding, microcirculatory symptoms, pruritus, and risk of leukemic or fibrotic transformation." | 1.46 | Polycythemia vera and essential thrombocythemia: 2017 update on diagnosis, risk-stratification, and management. ( Barbui, T; Tefferi, A, 2017) |
| "Treatment with hydroxyurea resulted in rapid improvement in proteinuria that correlated with a decrease in hematocrit." | 1.43 | Hydroxyurea for Treatment of Nephrotic Syndrome Associated With Polycythemia Vera. ( Chen, YB; Colvin, RB; Hundemer, GL; Rosales, IA; Tolkoff-Rubin, NE, 2016) |
| " During the subsequent 12 mo, the hydroxyurea dose adjusted according to follow-up CBC results, and finding an optimal dosage regimen proved to be challenging." | 1.43 | Diagnosis and Management of Polycythemia Vera in a Ferret ( ( Bassel, LL; Beaufrère, H; Blois, SL; Laniesse, D; Le, K; Smith, DA; Wills, S, 2016) |
| " We observed that long-term maintenance with hydroxyurea at a dosage of 15 mg/kg every 48 hours was adequate for managing polycythemia vera, with a survival time of 18 months in the present case." | 1.42 | Diagnosis and Treatment of Primary Erythrocytosis in a Dog: A Case Report. ( Arias, MV; Bonelli, Mde A; Camassa, JA; Diogo, CC; Fabretti, AK; Pereira, PM, 2015) |
| "Chronic inflammation is suggested to contribute to the Philadelphia-chromosome-negative myeloproliferative neoplasm (MPN) disease initiation and progression, as well as the development of premature atherosclerosis and may drive the development of other cancers in MPNs, both nonhematologic and hematologic." | 1.40 | Perspectives on the impact of JAK-inhibitor therapy upon inflammation-mediated comorbidities in myelofibrosis and related neoplasms. ( Hasselbalch, HC, 2014) |
| "At present, the treatment of polycythemia vera (PV) and essential thrombocythemia (ET) is still largely supportive and symptomatic." | 1.39 | Homoharringtonine is an effective therapy for patients with polycythemia vera or essential thrombocythemia who have failed or were intolerant to hydroxycarbamide or interferon-α therapy. ( Ding, B; Li, Y; Zhu, J, 2013) |
| "Diagnosis of post-PV myelofibrosis is established according to the International Working Group for Myeloproliferative Neoplasms Research and Treatment criteria." | 1.38 | How I treat polycythemia vera. ( Passamonti, F, 2012) |
| "Twenty-one polycythemia vera, 28 essential thrombocythemia, eight secondary erythrocytosis, and 30 controls were studied." | 1.37 | Differential expression of JAK2 and Src kinase genes in response to hydroxyurea treatment in polycythemia vera and essential thrombocythemia. ( Albizua, E; Ayala, R; Barrio, S; Besses, C; Espinet, B; Florensa, L; Gallardo, M; Jimenez, A; Martinez-Lopez, J; Puigdecanet, E; Rapado, I; Rueda, D; Sanchez-Espiridion, B, 2011) |
| "Mechanical valve thrombosis is a rare condition in an adequately anticoagulated patient in the absence of underlying thrombophilia." | 1.37 | Anticoagulant-resistant thrombophilia in a patient with polycythemia vera: a case report. ( Cherian, SV; Das, S; Gajra, A; Garcha, AS; Jasti, S; Karachiwala, H, 2011) |
| "Leg ulcers are a frequent and serious complication of polycythemia vera (PV)." | 1.36 | [Leg ulcers in patient affected by polycythemia vera in treatment with hydroxycarbamide. Case report]. ( Alfano, C; Arleo, S; Chiummariello, S, 2010) |
| "Hydroxyurea (HU) is a cytotoxic agent, which leads to inactivation of ribonucleotide reductase, inhibition of cellular DNA synthesis, and cell death in the S phase." | 1.34 | Hydroxyurea associated leg ulcer succesfully treated with hyperbaric oxygen in a diabetic patient. ( Akinci, B; Atabey, A; Ilgezdi, S; Yesil, S, 2007) |
| "We report a rare case of eosinophilic leukemia transformation in a patient with polycythemia rubra vera on hydroxycarbamide (hydroxyurea) therapy only." | 1.33 | Eosinophilic leukemic transformation in polycythemia rubra vera (PRV). ( Chim, CS; Ma, SK, 2005) |
| "Hydroxyurea (HU) is an antineoplastic drug commonly used to treat chronic myeloproliferative disorders." | 1.33 | Hydroxyurea induced perimalleolar ulcers. ( Lakshmi, N; Saravu, K; Shastry, BA; Thomas, J; Velappan, P, 2006) |
| "(1) Stroke secondary to PV should be treated with stroke regimen as well as PV therapy, and hydroxycarbamide might have stable benefit and few side effects." | 1.33 | [The diagnosis and treatment of polycythemia rubra vera manifesting as acute cerebral stroke]. ( Ji, XM; Jia, JP; Li, LM; Meng, R; Yang, BF; Zhou, J, 2006) |
| "A 60-year-old white woman with polycythemia rubra vera post splenectomy in November 2001 was found to have peripheral white blood cell counts increasing over 3 months." | 1.32 | Paraneoplastic eosinophilic fasciitis: a case report. ( Cohen, JJ; Jacob, SE; Kirsner, RS; Lodha, R; Romanelli, P, 2003) |
| "Hydroxyurea (HU) is a good-controllable and well-tolerated cytostatic drug." | 1.32 | [Hydroxyurea-induced pneumonitis]. ( Schwonzen, M; Spangenberger, H; Spengler, M, 2003) |
| "Hydroxyurea and myelosan were mostly used as cytostatic drugs while erythrocyte mass transfusions and hemoexfusions (phlebotomy)--for life-support." | 1.32 | [Choice of therapy and overall survival in patients with chronic myeloproliferative diseases]. ( Pop, VP; Rukavitsyn, OA; Seriakov, AP, 2004) |
| "Hydroxyurea, which is a cell-cycle-specific agent, probably exacerbates the periodicity which may be present in some patients with myeloproliferative disease." | 1.31 | Hydroxyurea and periodicity in myeloproliferative disease. ( Bennett, M; Grunwald, AJ, 2001) |
| "Bone marrow examinations reveal chromosomal abnormalities in 15-43% of PV patients and 5% of ET patients, but no specific recurring abnormality has been found to date." | 1.31 | Comparative genomic hybridization in polycythemia vera and essential thrombocytosis patients. ( Amiel, A; Bomstein, Y; Fejgin, MD; Gaber, E; Herishanu, Y; Kitay-Cohen, Y; Lishner, M, 2001) |
| "Polycythemia vera is an extremely uncommon disease in childhood and for this reason its treatment is not well established." | 1.31 | Polycythemia vera in a 12-year-old girl: a case report. ( Atabay, B; Oniz, H; Ozer, EA; Turker, M; Yaprak, I, 2002) |
| "However, thrombosis is not sufficiently predictable with standard diagnostic procedures." | 1.30 | APC resistance as an additional thrombotic risk factor in a patient suffering from polycythemia vera and recurrent thrombosis. ( Heidtmann, HH; Lamparter, S; Schuermann, M, 1997) |
| "Lawrence and the use of 32P as a treatment for polycythemia vera, to the formation of French and Italian polycythemia study groups." | 1.30 | Polycythemia vera: a retrospective and reprise. ( Berlin, NI; Wasserman, LR, 1997) |
| "Hydroxyurea was given to patients with ET with a positive history for major vascular complications or with an extreme thrombocytosis." | 1.30 | Acute coronary disease in essential thrombocythemia and polycythemia vera. ( Girolami, A; Randi, ML; Rinaldi, V; Rossi, C; Zerbinati, P, 1998) |
| "Polycythemia vera is a very rare disease in childhood; its treatment for this reason is not well established." | 1.29 | [Treatment with hydroxyurea of polycythemia vera in a 11 year-old child]. ( Farriaux, JP; Nelken, B; Vic, P; Vodoff, MV, 1996) |
| "Hydroxyurea is an effective agent in the treatment of PV, but continued assessment of its mutagenic potential is necessary." | 1.27 | Treatment of polycythemia vera with hydroxyurea. ( Berk, PD; Donovan, PB; Goldberg, JD; Kaplan, ME; Knospe, WH; Laszlo, J; Mack, K; Najean, Y; Silberstein, EB; Tatarsky, I, 1984) |
| "A patient with postpolycythemic myeloid metaplasia who previously underwent splenectomy presented with recurrent, protracted gastrointestinal tract hemorrhage." | 1.27 | Small intestinal myeloid metaplasia. ( Alroy, G; Ben-Arieh, Y; Brenner, B; Jacobs, R; Schreibman, D; Tatarsky, I, 1988) |
| "Treatment with hydroxyurea was followed by a dramatic response of both the polycythemia vera and the HES, with return to normal of the abnormal immunologic measures." | 1.27 | Hypereosinophilic syndrome associated with polycythemia vera. ( Berrebi, A; Varon, D; Wetzler, M, 1986) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 21 (5.65) | 18.7374 |
| 1990's | 54 (14.52) | 18.2507 |
| 2000's | 95 (25.54) | 29.6817 |
| 2010's | 145 (38.98) | 24.3611 |
| 2020's | 57 (15.32) | 2.80 |
| Authors | Studies |
|---|---|
| Sekhri, R | 1 |
| Sadjadian, P | 1 |
| Becker, T | 1 |
| Kolatzki, V | 1 |
| Huenerbein, K | 1 |
| Meixner, R | 1 |
| Marchi, H | 1 |
| Wallmann, R | 1 |
| Fuchs, C | 1 |
| Griesshammer, M | 12 |
| Wille, K | 2 |
| Crodel, CC | 1 |
| Jentsch-Ullrich, K | 1 |
| Reiser, M | 1 |
| Jacobasch, L | 1 |
| Sauer, A | 1 |
| Tesch, H | 1 |
| Ulshöfer, T | 1 |
| Wunschel, R | 1 |
| Palandri, F | 6 |
| Heidel, FH | 2 |
| Gambichler, T | 1 |
| Stockfleth, E | 1 |
| Susok, L | 1 |
| Mascarenhas, J | 8 |
| Passamonti, F | 18 |
| Burbury, K | 1 |
| El-Galaly, TC | 1 |
| Gerds, A | 1 |
| Gupta, V | 2 |
| Higgins, B | 1 |
| Wonde, K | 1 |
| Jamois, C | 1 |
| Kovic, B | 1 |
| Huw, LY | 1 |
| Katakam, S | 1 |
| Maffioli, M | 3 |
| Mesa, R | 9 |
| Palmer, J | 1 |
| Bellini, M | 1 |
| Ross, DM | 2 |
| Vannucchi, AM | 24 |
| Yacoub, A | 5 |
| Mazza, GL | 1 |
| Mead-Harvey, C | 1 |
| Kosiorek, HE | 2 |
| Hoffman, R | 6 |
| Dueck, AC | 4 |
| Mesa, RA | 7 |
| Liu, D | 1 |
| Xu, Z | 2 |
| Zhang, P | 2 |
| Qin, T | 1 |
| Sun, X | 2 |
| Qu, S | 1 |
| Pan, L | 1 |
| Ma, J | 1 |
| Cai, W | 1 |
| Liu, J | 1 |
| Wang, H | 1 |
| Sun, Q | 1 |
| Shi, Z | 1 |
| Huang, H | 1 |
| Huang, G | 1 |
| Gale, RP | 3 |
| Li, B | 1 |
| Rampal, RK | 4 |
| Xiao, Z | 3 |
| Prchal, JT | 5 |
| Rambaldi, A | 10 |
| Berenzon, D | 3 |
| Harrison, CN | 10 |
| McMullin, MF | 7 |
| Ewing, J | 1 |
| O'Connell, CL | 1 |
| Kiladjian, JJ | 16 |
| Mead, AJ | 1 |
| Winton, EF | 1 |
| Leibowitz, DS | 1 |
| De Stefano, V | 7 |
| Arcasoy, MO | 2 |
| Kessler, CM | 1 |
| Catchatourian, R | 2 |
| Rondelli, D | 2 |
| Silver, RT | 9 |
| Bacigalupo, A | 1 |
| Nagler, A | 2 |
| Kremyanskaya, M | 4 |
| Levine, MF | 1 |
| Arango Ossa, JE | 1 |
| McGovern, E | 1 |
| Sandy, L | 2 |
| Salama, ME | 2 |
| Najfeld, V | 2 |
| Tripodi, J | 2 |
| Farnoud, N | 2 |
| Penson, AV | 1 |
| Weinberg, RS | 1 |
| Price, L | 1 |
| Goldberg, JD | 5 |
| Barbui, T | 28 |
| Marchioli, R | 3 |
| Tognoni, G | 2 |
| Marchetti, M | 4 |
| Harrison, C | 6 |
| Koschmieder, S | 3 |
| Gisslinger, H | 3 |
| Álvarez-Larrán, A | 11 |
| Guglielmelli, P | 9 |
| Barosi, G | 6 |
| Hehlmann, R | 2 |
| Duek, A | 1 |
| Berla, M | 1 |
| Ellis, MH | 1 |
| Laktib, N | 1 |
| Mahtat, EM | 1 |
| Lahlafi, Z | 1 |
| Mouine, N | 1 |
| Asfalou, I | 1 |
| Aghoutane, N | 1 |
| Chaib, A | 1 |
| Lakhal, Z | 1 |
| Doghmi, K | 1 |
| Benyass, A | 1 |
| Edahiro, Y | 4 |
| Garrote, M | 2 |
| Ferrer-Marín, F | 5 |
| Pérez-Encinas, M | 4 |
| Mata-Vazquez, MI | 1 |
| Bellosillo, B | 7 |
| Arellano-Rodrigo, E | 2 |
| Gómez, M | 5 |
| García, R | 1 |
| García-Gutiérrez, V | 4 |
| Gasior, M | 1 |
| Cuevas, B | 3 |
| Angona, A | 6 |
| Gómez-Casares, MT | 5 |
| Martínez, CM | 1 |
| Magro, E | 2 |
| Ayala, R | 2 |
| Del Orbe-Barreto, R | 1 |
| Pérez-López, R | 1 |
| Fox, ML | 3 |
| Raya, JM | 3 |
| Guerrero, L | 1 |
| García-Hernández, C | 2 |
| Caballero, G | 2 |
| Murillo, I | 1 |
| Xicoy, B | 2 |
| Ramírez, MJ | 2 |
| Carreño-Tarragona, G | 2 |
| Hernández-Boluda, JC | 7 |
| Pereira, A | 2 |
| Nicol, C | 1 |
| Ajzenberg, N | 1 |
| Lacut, K | 1 |
| Couturaud, F | 1 |
| Lippert, E | 2 |
| Pan-Petesch, B | 2 |
| Ianotto, JC | 3 |
| Saydam, G | 4 |
| Callum, J | 1 |
| Devos, T | 4 |
| Zor, E | 1 |
| Zuurman, M | 1 |
| Gilotti, G | 1 |
| Zhang, Y | 2 |
| Venugopal, S | 1 |
| Verstovsek, S | 12 |
| Chiaranairungrot, K | 1 |
| Kaewpreechawat, K | 1 |
| Sajai, C | 1 |
| Pagowong, N | 1 |
| Sukarat, N | 1 |
| Piriyakhuntorn, P | 1 |
| Rattanathammethee, T | 1 |
| Hantrakool, S | 1 |
| Chai-Adisaksopha, C | 1 |
| Tantiworawit, A | 1 |
| Norasetthada, L | 1 |
| Rattarittamrong, E | 1 |
| Wang, R | 1 |
| Shallis, RM | 1 |
| Stempel, JM | 1 |
| Huntington, SF | 1 |
| Zeidan, AM | 2 |
| Gore, SD | 1 |
| Ma, X | 1 |
| Podoltsev, NA | 1 |
| Mora, B | 3 |
| Kuykendall, A | 1 |
| Rumi, E | 6 |
| Caramella, M | 1 |
| Salmoiraghi, S | 2 |
| Gotlib, J | 2 |
| Iurlo, A | 4 |
| Cervantes, F | 5 |
| Ruggeri, M | 4 |
| Albano, F | 1 |
| Benevolo, G | 3 |
| Della Porta, MG | 1 |
| Rotunno, G | 1 |
| Komrokji, RS | 2 |
| Casetti, IC | 2 |
| Merli, M | 1 |
| Brociner, M | 1 |
| Caramazza, D | 2 |
| Auteri, G | 1 |
| Cattaneo, D | 2 |
| Bertù, L | 1 |
| Arcaini, L | 1 |
| Pan, DQ | 1 |
| Zhao, WS | 1 |
| Yin, CX | 1 |
| He, H | 1 |
| Lin, R | 1 |
| Zhao, K | 1 |
| Ye, JY | 1 |
| Liu, QF | 1 |
| Dai, M | 1 |
| Chang, L | 1 |
| Duan, MH | 1 |
| Dam, MJB | 2 |
| Pedersen, RK | 2 |
| Knudsen, TA | 3 |
| Andersen, M | 2 |
| Ellervik, C | 2 |
| Larsen, MK | 2 |
| Kjaer, L | 2 |
| Skov, V | 3 |
| Hasselbalch, HC | 6 |
| Ottesen, JT | 2 |
| Eickhardt-Dalbøge, CS | 1 |
| Ingham, AC | 1 |
| Andersen, LO | 1 |
| Nielsen, HV | 1 |
| Fuursted, K | 1 |
| Stensvold, CR | 1 |
| Kjær, L | 1 |
| Christensen, SF | 1 |
| Olsen, LR | 1 |
| Nielsen, XC | 1 |
| Christensen, JJE | 1 |
| Palumbo, GA | 1 |
| Breccia, M | 2 |
| Baratè, C | 1 |
| Bonifacio, M | 2 |
| Elli, EM | 2 |
| Pugliese, N | 1 |
| Rossi, E | 1 |
| Isfort, S | 1 |
| Wolf, D | 1 |
| Hochhaus, A | 1 |
| Schafhausen, P | 1 |
| Wolleschak, D | 1 |
| Platzbecker, U | 1 |
| Döhner, K | 2 |
| Jost, PJ | 1 |
| Parmentier, S | 1 |
| Schaich, M | 1 |
| von Bubnoff, N | 1 |
| Stegelmann, F | 2 |
| Maurer, A | 1 |
| Crysandt, M | 1 |
| Gezer, D | 1 |
| Kortmann, M | 1 |
| Franklin, J | 1 |
| Frank, J | 1 |
| Hellmich, M | 1 |
| Brümmendorf, TH | 1 |
| Cilia, K | 1 |
| Borg, J | 1 |
| Bugeja, M | 1 |
| Farrugia, E | 1 |
| Le Gall-Ianotto, C | 1 |
| Ficheux, AS | 1 |
| Herbreteau, L | 1 |
| Rio, L | 1 |
| Misery, L | 1 |
| Kuykendall, AT | 1 |
| Abu-Zeinah, G | 1 |
| Jin, J | 1 |
| Qin, A | 1 |
| Zhang, L | 1 |
| Shen, W | 1 |
| Wang, W | 1 |
| Zhang, J | 1 |
| Li, Y | 2 |
| Wu, D | 1 |
| Oguro, H | 1 |
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| Gerds, AT | 4 |
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| Flynn, MM | 1 |
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| Nalçacı, M | 1 |
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| Kosiorek, H | 2 |
| Baer, MR | 1 |
| Ritchie, E | 1 |
| Kessler, C | 1 |
| Winton, E | 1 |
| Finazzi, MC | 3 |
| Leibowitz, D | 1 |
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| Hexner, E | 1 |
| Papaemmanuil, E | 1 |
| Salama, M | 1 |
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| Zachee, P | 4 |
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| Pane, F | 4 |
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| Kirito, K | 3 |
| Besses, C | 12 |
| Moiraghi, B | 1 |
| Blau, IW | 1 |
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| Spivak, JL | 3 |
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| Altomare, I | 2 |
| Burke, JM | 1 |
| Walshauser, MA | 1 |
| Savona, MR | 1 |
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| Oh, ST | 3 |
| Colucci, P | 2 |
| Parasuraman, S | 2 |
| Paranagama, D | 2 |
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| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Phase II, Single-Arm, Open-Label Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Patients With Hydroxyurea-Resistant/Intolerant Polycythemia Vera[NCT03287245] | Phase 2 | 27 participants (Actual) | Interventional | 2018-02-21 | Terminated (stopped due to The Sponsor decided to discontinue the development of idasanutlin in the polycythemia vera indication.) | ||
| Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea Therapy in the Treatment of High Risk Polycythemia Vera (PV) and High Risk Essential Thrombocythemia (ET)[NCT01259856] | Phase 3 | 168 participants (Actual) | Interventional | 2011-09-30 | Completed | ||
| Mechanism of Action of Interferon in the Treatment of Myeloproliferative Neoplasms[NCT05850273] | 50 participants (Anticipated) | Observational | 2023-03-16 | Recruiting | |||
| Randomized, Open Label, Multicenter Phase IIIb Study Evaluating the Efficacy and Safety of Ruxolitinib Versus Best Available Therapy in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant (Response 2)[NCT02038036] | Phase 3 | 149 participants (Actual) | Interventional | 2014-03-25 | Completed | ||
| Randomized, Open Label, Multicenter Phase III Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 Tablets Versus Best Available Care (The RESPONSE Trial)[NCT01243944] | Phase 3 | 222 participants (Actual) | Interventional | 2010-10-27 | Completed | ||
| Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG)[NCT04901325] | Phase 2 | 10 participants (Anticipated) | Interventional | 2023-10-31 | Recruiting | ||
| French Aspirin Study in Essential Thrombocythemia: an Open and Randomized Study[NCT02611973] | Phase 3 | 2,250 participants (Anticipated) | Interventional | 2016-03-10 | Recruiting | ||
| The Benefit/Risk Profile of Pegylated Proline-Interferon Alpha-2b (AOP2014) Added to the Best Available Strategy Based on Phlebotomies in Low-risk Patients With Polycythemia Vera (PV). The Low-PV Randomized Trial[NCT03003325] | Phase 2 | 127 participants (Actual) | Interventional | 2017-02-02 | Completed | ||
| A Large-scale Trial Testing the Intensity of CYTOreductive Therapy to Prevent Cardiovascular Events In Patients With Polycythemia Vera (PV)[NCT01645124] | Phase 3 | 365 participants (Actual) | Interventional | 2008-05-31 | Terminated (stopped due to Low accrual rate not allowing planned sample size leads to a futility condition) | ||
| Multicenter Phase 2 Study of Efficacy and Safety of Pegylated Interferon-alfa 2a in Polycythemia Vera Patients[NCT00241241] | Phase 2 | 40 participants | Interventional | 2004-09-30 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Complete hematologic remission requires all of the following: Hct control without phlebotomy between Weeks 32 and Cycle 11 Day 28; WBC count ≤10 × 10^9/L at Cycle 11 Day 28; and Platelet count ≤400 × 10^9/L at Week 32. Hct control is defined as protocol-specified ineligibility for phlebotomy. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of >48%. (NCT03287245)
Timeframe: Cycle 11 Day 28
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | 40 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | 100 |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 0 |
Complete hematologic response requires all of the following: Hct control without phlebotomy; White blood cell (WBC) count ≤10 × 10^9/Liter (L) at Week 32; and Platelet count ≤400 × 10^9/L at Week 32. Hct control is defined as protocol-specified ineligibility for phlebotomy between Weeks 8 to 32 and ≤1 instance of phlebotomy eligibility between first dose and Week 8. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of >48%. (NCT03287245)
Timeframe: Week 32 (Cycle 8 Day 28)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ruxolitinib-naïve Participants With Splenomegaly | 33.3 |
| Ruxolitinib-naïve Participants Without Splenomegaly | 100 |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 75.0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 0 |
Hct control is defined as protocol-specified ineligibility for phlebotomy between Weeks 8 to 32 and ≤1 instance of phlebotomy eligibility between first dose and Week 8. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of >48%. (NCT03287245)
Timeframe: Week 32
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | 44.4 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | 100 |
| Total Ruxolitinib-Naïve Participants | 54.5 |
Hct control is defined as protocol-specified ineligibility for phlebotomy between Weeks 8 to 32 and ≤1 instance of phlebotomy eligibility between first dose and Week 8. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of >48%. (NCT03287245)
Timeframe: From Baseline to Week 32 (Cycle 8 Day 28)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 75.0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 0 |
| Total Ruxolitinib-Resistant or Intolerant Participants | 60 |
"Clinical chemistry parameter laboratory values falling outside the standard reference range were to be recorded as either high or low.~There was no clinical chemistry abnormalities identified. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study." (NCT03287245)
Timeframe: Baseline to end of study (up to 2 years)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | 0 |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 0 |
"Hematology parameter laboratory values falling outside the standard reference range were planned to be recorded as either high or low.~There was no clinical laboratory abnormalities identified. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study." (NCT03287245)
Timeframe: Baseline to end of study (up to 2 years)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | 0 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | 0 |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 0 |
"Urinalysis parameter laboratory values falling outside the standard reference range were planned to be recorded as either high or low.~There was no clinical laboratory (urinalysis) abnormalities identified. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study." (NCT03287245)
Timeframe: Baseline to end of study (up to 2 years)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ruxolitinib-naïve Participants With Splenomegaly | 0 |
| Ruxolitinib-naïve Participants Without Splenomegaly | 0 |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 0 |
"Participants with Concomitant Medications used from 28 days prior to screening until the final visit or end of study (EOS) were reported.~The result data not derived due to early termination of the study by the sponsor's decision and did not reach the end of study." (NCT03287245)
Timeframe: Overall Study Period
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ruxolitinib-naïve Participants With Splenomegaly | 100 |
| Ruxolitinib-naïve Participants Without SplenomegalyEdit | 100 |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 100 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 100 |
Composite response is defined as hematocrit (Hct) control without phlebotomy and ≥35% decrease in spleen size by imaging at Week 32. Hct control is defined as protocol-specified ineligibility for phlebotomy between Weeks 8 to 32 and ≤1 instance of phlebotomy eligibility between first dose and Week 8. Eligibility for phlebotomy is defined as a Hct of ≥45% that was ≥3% higher than baseline level or a Hct of >48%. One Cycle is 28 Days. (NCT03287245)
Timeframe: Week 32
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ruxolitinib-Naïve Participants With Splenomegaly | 44.4 |
Hct control is defined as protocol-specified ineligibility for phlebotomy between Weeks 8 to 32 and ≤1 instance of phlebotomy eligibility between first dose and Week 8. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of >48%. (NCT03287245)
Timeframe: Week 32
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ruxolitinib-Naïve Participants Without Splenomegaly | 100 |
"Reported EORTC QLQ-C30 Scores include: Cognitive function, Diarrhea Emotional functioning, Nausea and vomiting, Social functioning, Physical functioning, Global health status/QoL and Role functioning. The questions use a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores are averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study." (NCT03287245)
Timeframe: Baseline (Cycle 1 Day 1), Cycle 2 Day 1, Cycles 3, 5, 8, 11, 14, 17, 20 Day 28 and Final Visit
| Intervention | Score on a Scale (Mean) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EORTC QLQ-C30 Scores: Cognitive function Baseline | EORTC QLQ-C30 Scores: Cognitive function Cycle 2, Day 1 | EORTC QLQ-C30 Scores: Cognitive function Cycle 3 Day 28 | EORTC QLQ-C30 Scores: Cognitive function Cycle 5 Day 28 | EORTC QLQ-C30 Scores: Cognitive function Cycle 8 (Week 32) | EORTC QLQ-C30 Scores: Cognitive function Cycle 11 Day 28 | EORTC QLQ-C30 Scores: Cognitive function Cycle 14 Day 28 | EORTC QLQ-C30 Scores: Cognitive function Cycle 17 Day 28 | EORTC QLQ-C30 Scores: Cognitive function Cycle 20 Day 28 | EORTC QLQ-C30 Scores: Cognitive function Final Visit | EORTC QLQ-C30 Scores: Diarrhea Baseline | EORTC QLQ-C30 Scores: Diarrhea Cycle 2 Day 1 | EORTC QLQ-C30 Scores: Diarrhea Cycle 3 Day 28 | EORTC QLQ-C30 Scores: Diarrhea Cycle 5 Day 28 | EORTC QLQ-C30 Scores: Diarrhea Cycle 8 (Week 32) | EORTC QLQ-C30 Scores: Diarrhea Cycle 11 Day 28 | EORTC QLQ-C30 Scores: Diarrhea Cycle 14 Day 28 | EORTC QLQ-C30 Scores: Diarrhea Cycle 17 Day 28 | EORTC QLQ-C30 Scores: Diarrhea Cycle 20 Day 28 | EORTC QLQ-C30 Scores: Diarrhea Final visit | EORTC QLQ-C30 Scores: Emotional functioning Baseline | EORTC QLQ-C30 Scores: Emotional functioning Cycle 1 Day 28 | EORTC QLQ-C30 Scores: Emotional functioning Cycle 3 Day 28 | EORTC QLQ-C30 Scores: Emotional functioning Cycle 5 Day 28 | EORTC QLQ-C30 Scores: Emotional functioning Cycle 8 (Week 32) | EORTC QLQ-C30 Scores: Emotional functioning Cycle 11 Day 28 | EORTC QLQ-C30 Scores: Emotional functioning Cycle 14 Day 28 | EORTC QLQ-C30 Scores: Emotional functioning Cycle 17 Day 28 | EORTC QLQ-C30 Scores: Emotional functioning Cycle 20 Day 28 | EORTC QLQ-C30 Scores: Emotional functioning Final visit | EORTC QLQ-C30 Scores: Nausea and vomiting Baseline | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 2 Day 1 | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 3 Day 28 | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 5 Day 28 | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 8 (Week 32) | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 11 Day 28 | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 14 Day 28 | EORTC QLQ-C30 Scores: Nausea and vomiting Cycle 20 Day 28 | EORTC QLQ-C30 Scores: Nausea and vomiting Final visit | EORTC QLQ-C30 Scores: Social functioning Baseline | EORTC QLQ-C30 Scores: Social functioning Cycle 2 Day 1 | EORTC QLQ-C30 Scores: Social functioning Cycle 3 Day 28 | EORTC QLQ-C30 Scores: Social functioning Cycle 5 Day 28 | EORTC QLQ-C30 Scores: Social functioning Cycle 8 (Week 32) | EORTC QLQ-C30 Scores: Social functioning Cycle 11 Day 28 | EORTC QLQ-C30 Scores: Social functioning Cycle 14 Day 28 | EORTC QLQ-C30 Scores: Social functioning Cycle 17 Day 28 | EORTC QLQ-C30 Scores: Social functioning Cycle 20 Day 28 | EORTC QLQ-C30 Scores: Social functioning Final visit | EORTC QLQ-C30 Scores: Physical functioning Baseline | EORTC QLQ-C30 Scores: Physical functioning Cycle 2 Day 1 | EORTC QLQ-C30 Scores: Physical functioning Cycle 3 Day 28 | EORTC QLQ-C30 Scores: Physical functioning Cycle 5 Day 28 | EORTC QLQ-C30 Scores: Physical functioning Cycle 8 (Week 32) | EORTC QLQ-C30 Scores: Physical functioning Cycle 11 Day 28 | EORTC QLQ-C30 Scores: Physical functioning Cycle 14 Day 28 | EORTC QLQ-C30 Scores: Physical functioning Cycle 17 Day 28 | EORTC QLQ-C30 Scores: Physical functioning Cycle 20 Day 28 | EORTC QLQ-C30 Scores: Physical functioning Final visit | EORTC QLQ-C30 Scores: Global health status/QoL Baseline | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 2 Day 1 | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 3 Day 28 | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 5 Day 28 | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 8 (Week 32) | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 11 Day 28 | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 14 Day 28 | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 17 Day 28 | EORTC QLQ-C30 Scores: Global health status/QoL Cycle 20 Day 28 | EORTC QLQ-C30 Scores: Global health status/QoL Final visit | EORTC QLQ-C30 Scores: Role functioning Baseline | EORTC QLQ-C30 Scores: Role functioning Cycle 2 Day 1 | EORTC QLQ-C30 Scores: Role functioning Cycle 3 Day 28 | EORTC QLQ-C30 Scores: Role functioning Cycle 5 Day 28 | EORTC QLQ-C30 Scores: Role functioning Cycle 8 (Week 32) | EORTC QLQ-C30 Scores: Role functioning Cycle 11 Day 28 | EORTC QLQ-C30 Scores: Role functioning Cycle 14 Day 28 | EORTC QLQ-C30 Scores: Role functioning Cycle 17 Day 28 | EORTC QLQ-C30 Scores: Role functioning Cycle 20 Day 28 | EORTC QLQ-C30 Scores: Role functioning Final Visit | |
| Ruxolitinib-Naïve Participants | 65.83 | 11.11 | 7.02 | 1.19 | 6.06 | 8.33 | 5.56 | 0.00 | 0 | 4.44 | 8.33 | -5.56 | 1.75 | 7.14 | 9.09 | 5.56 | 5.56 | 25.00 | 0 | 13.33 | 65.83 | 13.43 | 14.04 | 16.07 | 14.39 | 6.94 | 5.56 | -8.33 | 0 | 3.33 | 10.00 | -4.63 | -1.75 | -2.38 | 7.58 | 2.78 | -2.78 | 0 | 11.11 | 67.50 | 4.63 | -1.75 | 5.95 | 0.00 | 0.00 | 0.00 | -4.17 | 0 | 0.00 | 86.33 | 1.48 | -2.81 | 1.43 | 5.45 | -1.11 | -1.11 | 1.67 | 0 | -4.44 | 61.25 | 2.31 | 7.89 | 7.14 | 9.09 | 1.39 | 2.78 | 10.42 | 25.00 | -3.33 | 74.17 | 7.41 | 2.63 | 7.14 | 15.15 | -2.78 | 5.56 | 8.33 | 16.67 | -13.33 |
| Ruxolitinib-Resistant or Intolerant Participants | 76.19 | 8.33 | 6.67 | 11.11 | -3.33 | 0 | 0 | -8.33 | 0 | 6.67 | 14.29 | 5.56 | 0 | 5.56 | 20.00 | 0 | 0 | 0 | 0 | 6.67 | 64.29 | 15.28 | 8.33 | 6.94 | 5.00 | 16.67 | -4.17 | 0 | 8.33 | 16.67 | 2.38 | 8.33 | 3.33 | 8.33 | 16.67 | 0.00 | -8.33 | 0 | 6.67 | 76.19 | 0.00 | 3.33 | -2.78 | -6.67 | 0 | 0 | 0 | 0 | -6.67 | 81.90 | 2.22 | 2.67 | -2.22 | -4.00 | -10.00 | 0.00 | 0 | 0 | -2.67 | 60.71 | 1.39 | 11.67 | 0.00 | -8.33 | 8.33 | 8.33 | 16.67 | 25.00 | 13.33 | 76.19 | -8.33 | 0.00 | -2.78 | 0.00 | -8.33 | 0 | 0 | 0 | 6.67 |
"MPN-SAF Total Symptom Score is the sum of the following 10 items: early satiety, abdominal discomfort, inactivity, concentration issues, night sweats, Itching, Bone pain, Fever and Unintentional weight loss last 6 months and fatigue. The participant provides a severity score for each symptom on a scale of 0 as a minimum score (none/absent) to 10 (worst imaginable) as a maximum score.~Baseline (Cycle 1, Day 1) MPN-SAF total symptom score and the mean change from baseline score at each timepoint are reported. The change from baseline score was calculated by subtracting the post-baseline score from the baseline score.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study." (NCT03287245)
Timeframe: Baseline (Cycle 1 Day 1), Cycle 2 Day 1, Days 28 of Cycles 3, 5, 8 (Week 32), 11, 14, 17 ) Day 28, Cycle 5 Day 28, End of Cycle 8 (Week 32), and Final Visit
| Intervention | Score on a Scale (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (Cycle 1 Day 1) | Cycle 2 Day 1 | Cycle 3 Day 28 | Cycle 5 Day 28, | Week 32 | Cycle 11 Day 28 | Cycle 14 Day 28 | Cycle 17 Day 28 | Cycle 20 Day 28 | Final Visit | |
| Ruxolitinib-Naïve Participants | 31.95 | -5.06 | -6.38 | -7.00 | -8.20 | -4.60 | -4.67 | -3.25 | -12.00 | -5.92 |
| Ruxolitinib-Resistant or Intolerant Participants | 26.00 | 0.80 | -8.00 | -9.50 | -5.00 | -7.50 | -10.50 | -12.00 | -8.00 | -7.20 |
"Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Millimeters of mercury (mmHg) (Mean) | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle1, Day 15 | Cycle 1, Day 22 | Cycle 2, Day 1 | Cycle 2, Day 15 | Cycle 3 Day 1 | Cycle 3, Day 15 | Cycle 4, Day 1 | Cycle 5, Day 1 | Cycle 6, Day 1 | Cycle 7, Day 1 | Cycle 8, Day 1 | Cycle 9, Day 1 | Cycle 10, Day 1 | Cycle 11, Day 1 | Cycle 12, Day 1 | Cycle 13, Day 1 | Cycle 14, Day 1 | Cycle 15, Day 1 | Cycle 16, Day 1 | Cycle 17, Day 1 | Final visit | |
| Ruxolitinib-naïve Participants Without Splenomegaly | 73.2 | 10.0 | 2.4 | 3.0 | 2.5 | 5.8 | 2.0 | 2.7 | 5.0 | 3.3 | 4.5 | 5.0 | 4.0 | 5.0 | 10.0 | 6.0 | 4.0 | 19.0 | 10.0 | 11.0 | 11.0 | 3.8 |
"Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Millimeters of mercury (mmHg) (Mean) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle1, Day 15 | Cycle 1, Day 22 | Cycle 2, Day 1 | Cycle 2, Day 15 | Cycle 3 Day 1 | Cycle 3, Day 15 | Cycle 4, Day 1 | Cycle 5, Day 1 | Cycle 6, Day 1 | Cycle 7, Day 1 | Cycle 8, Day 1 | Cycle 9, Day 1 | Cycle 10, Day 1 | Cycle 11, Day 1 | Cycle 12, Day 1 | Cycle 13, Day 1 | Cycle 14, Day 1 | Cycle 15, Day 1 | Cycle 16, Day 1 | Cycle 17, Day 1 | Cycle 18, Day 1 | Cycle 19, Day 1 | Cycle 20, Day 1 | Final visit | |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 72.3 | -1.8 | -2.2 | -0.2 | -5.5 | -4.0 | -7.5 | -0.4 | -5.0 | -2.0 | -5.3 | 0.5 | -2.7 | -2.3 | 1.0 | 2.0 | 2.0 | -9.0 | -2.0 | 7.0 | 3.0 | -2.0 | 5.0 | -1.0 | -2.0 |
"Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Millimeters of mercury (mmHg) (Mean) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle1, Day 15 | Cycle 1, Day 22 | Cycle 2, Day 1 | Cycle 2, Day 15 | Cycle 3 Day 1 | Cycle 3, Day 15 | Cycle 4, Day 1 | Cycle 5, Day 1 | Cycle 6, Day 1 | Cycle 7, Day 1 | Cycle 8, Day 1 | Cycle 9, Day 1 | Cycle 10, Day 1 | Cycle 11, Day 1 | Cycle 12, Day 1 | Cycle 13, Day 1 | Cycle 14, Day 1 | Cycle 15, Day 1 | Cycle 16, Day 1 | Cycle 17, Day 1 | Cycle 18, Day 1 | Cycle 19, Day 1 | Cycle 20, Day 1 | Cycle 21, Day 1 | Cycle 22, Day 1 | Final visit | |
| Ruxolitinib-naïve Participants With Splenomegaly | 76.3 | 5.1 | 3.6 | 6.1 | 4.1 | 6.2 | 1.8 | 5.5 | 1.7 | 5.9 | 2.9 | 7.8 | 4.1 | 3.7 | 9.7 | 9.8 | 9.0 | 5.6 | 7.0 | 9.8 | 11.3 | 5.0 | 4.0 | 12.5 | -3.0 | 22.0 | 5.8 |
"Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Millimeters of mercury (mmHg) (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle1, Day 15 | Cycle 1, Day 22 | Cycle 2, Day 1 | Cycle 2, Day 15 | Cycle 3 Day 1 | Cycle 3, Day 15 | Cycle 4, Day 1 | Cycle 5, Day 1 | Cycle 6, Day 1 | Cycle 7, Day 1 | Cycle 8, Day 1 | Cycle 9, Day 1 | Cycle 10, Day 1 | Cycle 11, Day 1 | Cycle 12, Day 1 | Cycle 13, Day 1 | Cycle 14, Day 1 | Cycle 15, Day 1 | Cycle 16, Day 1 | Cycle 17, Day 1 | Cycle 18, Day 1 | Cycle 19, Day 1 | Cycle 20, Day 1 | Cycle 21, Day 1 | Cycle 22, Day 1 | Cycle 23, Day 1 | Final visit | |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 65.0 | 0.0 | -1.0 | 3.0 | 16.0 | 5.0 | 8.0 | 1.0 | 1.0 | 12.0 | 30.0 | 10.0 | 4.0 | 3.0 | 24.0 | 8.0 | 10.0 | 11.0 | 7.0 | 6.0 | 7.0 | 3.0 | 8.0 | 2.0 | 7.0 | 8.0 | 7.0 | 11.0 |
"Single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Day 1, hours 4 and 6, Day 2 pre-dose and 24 Hour, Day 5 pre-dose, 4 and 6 Hour), Cycle 2 (Day 1 pre-dose only), Cycle 3 (Day 1 pre-dose, 4 and 6 Hour), Cycle 4 (Day 1 pre-dose and 4 Hour)
| Intervention | Millisecond (msec) (Mean) | |||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PR Duration Baseline | PQ(PR) Durations Cycle 1, Day 1, 4 hour | PQ(PR) Durations Cycle 1, Day 1, 6 hour | PQ(PR) Durations Cycle 1, Day 2, 24 hour | PQ(PR) Durations Cycle ,1 Day 5, pre-dose | PQ(PR) Durations Cycle 1, Day 5, 4 hour | PQ(PR) Durations Cycle 1, Day 5, 6 hour | PQ(PR) Durations Cycle 2, Day1, pre-dose | QRS Duration Baseline | QRS Cycle 1 Day 1 (4 H) | QRS Cycle 1 Day 1 (6 H) | QRS Cycle 1 Day 2 (24 H) | QRS Cycle 1 Day 5 (PREDOSE) | QRS Cycle 1 Day 5 (4 H) | QRS Cycle 1 Day 5 (6 H) | QRS Cycle 2 Day 1 (PREDOSE) | QT Duration Baseline | QT Duration Cycle 1 Day 1 (4 H) | QT Duration Cycle 1 Day 1 (6 H) | QT Duration Cycle 1 Day 2 (24 H) | QT Duration Cycle 1 Day 5 (PREDOSE) | QT Duration Cycle 1 Day 5 (4 H) | QT Duration Cycle 1 Day 5 (6 H) | QT Duration Cycle 2 Day 1 (PREDOSE) | QTcB baseline | QTcB - Bazett's Correction Formula Cycle 1 Day 1 (4 H) | QTcB - Bazett's Correction Formula Cycle 1 Day 1 (6 H) | QTcB - Bazett's Correction Formula Cycle 1 Day 2 (24 H) | QTcB - Bazett's Correction Formula Cycle 1 Day 5 (PREDOSE) | QTcB - Bazett's Correction FormulaCycle 1 Day 5 (4 H) | QTcB - Bazett's Correction Formula Cycle 1 Day 5 (6 H) | QTcB - Bazett's Correction Formula Cycle 2 Day 1 (PREDOSE) | QTcF Durations Fridericia's Correction Formula Baseline | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 1 (4 H) | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 1 (6 H) | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 2 (24 H) | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (PREDOSE) | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (4 H) | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (6 H) | QTcF Durations Fridericia's Correction Formula Cycle 2 Day 1 (PREDOSE) | RR Duration Baseline | RR Duration Cycle 1 Day 1 4 H | RR Duration Cycle 1 Day 1 6 H | RR Duration Cycle 1 Day 2 (24 H) | RR Duration Cycle 1 Day 5 (PREDOSE) | RR Duration Cycle 1 Day 5 (4 H) | RR Duration Cycle 1 Day 5 (6 H) | RR Duration Cycle 2 Day 1 (PREDOSE) | |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 152.00 | -2.00 | 6.00 | 0.67 | 0.40 | -1.20 | 7.60 | -2.33 | 83.33 | 1.33 | 0.33 | 3.00 | 0.00 | -0.40 | 2.00 | 1.00 | 386.00 | 5.67 | -1.33 | 7.00 | 8.00 | 3.20 | 7.60 | 19.00 | 424.50 | 13.83 | 6.33 | 4.50 | -9.20 | -4.60 | -1.60 | 0.17 | 411.17 | 11.67 | 3.50 | 5.33 | -3.20 | -2.00 | 1.60 | 6.83 | 835.83 | -36.50 | -31.17 | 8.83 | 67.80 | 24.20 | 33.00 | 78.17 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 196.00 | 4.00 | 0.00 | -12.00 | -4.00 | 0 | 0 | -8.00 | 94.00 | 0 | -2.00 | -2.00 | 2.00 | 0 | 0 | -4.00 | 392.00 | 36.00 | 36.00 | 0 | 4.00 | -12.00 | -4.00 | 12.00 | 444.00 | -30.00 | 5.00 | -14.00 | -7.00 | 0.00 | -12.00 | -23.00 | 426.00 | -8.00 | 16.00 | -9.00 | -3.00 | -4.00 | 6.00 | -11.00 | 779.00 | 292.00 | 130.00 | 54.00 | 43.00 | -47.00 | -56.00 | 144.00 |
"Single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Day 1, hours 4 and 6, Day 2 pre-dose and 24 Hour, Day 5 pre-dose, 4 and 6 Hour), Cycle 2 (Day 1 pre-dose only), Cycle 3 (Day 1 pre-dose, 4 and 6 Hour), Cycle 4 (Day 1 pre-dose and 4 Hour)
| Intervention | Millisecond (msec) (Mean) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PR Duration Baseline | PQ(PR) Durations Cycle 1, Day 1, 4 hour | PQ(PR) Durations Cycle 1, Day 1, 6 hour | PQ(PR) Durations Cycle 1, Day 2, pre-dose | PQ(PR) Durations Cycle 1, Day 2, 24 hour | PQ(PR) Durations Cycle ,1 Day 5, pre-dose | PQ(PR) Durations Cycle 1, Day 5, 4 hour | PQ(PR) Durations Cycle 1, Day 5, 6 hour | PQ(PR) Durations Cycle 2, Day1, pre-dose | QRS Duration Baseline | QRS Cycle 1 Day 1 (4 H) | QRS Cycle 1 Day 1 (6 H) | QRS Cycle 1 Day 2 (PREDOSE) | QRS Cycle 1 Day 2 (24 H) | QRS Cycle 1 Day 5 (PREDOSE) | QRS Cycle 1 Day 5 (4 H) | QRS Cycle 1 Day 5 (6 H) | QRS Cycle 2 Day 1 (PREDOSE) | QT Duration Baseline | QT Duration Cycle 1 Day 1 (4 H) | QT Duration Cycle 1 Day 1 (6 H) | QT Duration Cycle 1 Day 2 (PREDOSE) | QT Duration Cycle 1 Day 2 (24 H) | QT Duration Cycle 1 Day 5 (PREDOSE) | QT Duration Cycle 1 Day 5 (4 H) | QT Duration Cycle 1 Day 5 (6 H) | QT Duration Cycle 2 Day 1 (PREDOSE) | QTcB baseline | QTcB - Bazett's Correction Formula Cycle 1 Day 1 (4 H) | QTcB - Bazett's Correction Formula Cycle 1 Day 1 (6 H) | QTcB - Bazett's Correction Formula Cycle 1 Day 2 (PREDOSE) | QTcB - Bazett's Correction Formula Cycle 1 Day 2 (24 H) | QTcB - Bazett's Correction Formula Cycle 1 Day 5 (PREDOSE) | QTcB - Bazett's Correction FormulaCycle 1 Day 5 (4 H) | QTcB - Bazett's Correction Formula Cycle 1 Day 5 (6 H) | QTcB - Bazett's Correction Formula Cycle 2 Day 1 (PREDOSE) | QTcF Durations Fridericia's Correction Formula Baseline | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 1 (4 H) | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 1 (6 H) | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 2 (PREDOSE) | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 2 (24 H) | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (PREDOSE) | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (4 H) | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (6 H) | QTcF Durations Fridericia's Correction Formula Cycle 2 Day 1 (PREDOSE) | RR Duration Baseline | RR Duration Cycle 1 Day 1 4 H | RR Duration Cycle 1 Day 1 6 H | RR Duration Cycle 1 Day 2 (PREDOSE) | RR Duration Cycle 1 Day 2 (24 H) | RR Duration Cycle 1 Day 5 (PREDOSE) | RR Duration Cycle 1 Day 5 (4 H) | RR Duration Cycle 1 Day 5 (6 H) | RR Duration Cycle 2 Day 1 (PREDOSE) | |
| Ruxolitinib-naïve Participants Without Splenomegaly | 153.60 | -2.60 | -4.40 | -6.00 | 1.00 | -12.00 | -6.25 | -2.75 | -5.75 | 83.80 | 4.60 | 4.00 | 2.00 | 1.75 | 4.00 | 3.75 | -0.25 | 7.75 | 392.60 | 16.80 | 11.00 | -18.00 | 2.75 | -8.75 | 15.25 | 4.75 | 10.50 | 419.60 | 21.00 | 8.40 | -410.00 | -0.75 | -10.00 | 1.50 | -4.75 | 7.75 | 410.00 | 18.80 | 10.00 | -20.00 | 0.00 | -9.25 | 4.00 | -2.25 | 8 | 881.00 | -5.60 | 14.00 | 18.00 | 17.25 | -0.75 | 79.75 | 49.50 | 23.75 |
"Single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Day 1, hours 4 and 6, Day 2 pre-dose and 24 Hour, Day 5 pre-dose, 4 and 6 Hour), Cycle 2 (Day 1 pre-dose only), Cycle 3 (Day 1 pre-dose, 4 and 6 Hour), Cycle 4 (Day 1 pre-dose and 4 Hour)
| Intervention | Millisecond (msec) (Mean) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PR Duration Baseline | PQ(PR) Durations Cycle 1, Day 1, 4 hour | PQ(PR) Durations Cycle 1, Day 1, 6 hour | PQ(PR) Durations Cycle 1, Day 2, pre-dose | PQ(PR) Durations Cycle 1, Day 2, 24 hour | PQ(PR) Durations Cycle ,1 Day 5, pre-dose | PQ(PR) Durations Cycle 1, Day 5, 4 hour | PQ(PR) Durations Cycle 1, Day 5, 6 hour | PQ(PR) Durations Cycle 2, Day1, pre-dose | PQ(PR) Durations Cycle 3, Day 1, pre-dose | PQ(PR) Durations Cycle 3, Day 1, 4 hour | PQ(PR) Durations Cycle 3, Day 1, 6 hour | PQ(PR) Durations Cycle 4, Day 1, pre-dose | PQ(PR) Durations Cycle 4, Day 1, 4 hour | QRS Duration Baseline | QRS Cycle 1 Day 1 (4 H) | QRS Cycle 1 Day 1 (6 H) | QRS Cycle 1 Day 2 (PREDOSE) | QRS Cycle 1 Day 2 (24 H) | QRS Cycle 1 Day 5 (PREDOSE) | QRS Cycle 1 Day 5 (4 H) | QRS Cycle 1 Day 5 (6 H) | QRS Cycle 2 Day 1 (PREDOSE) | QRS Cycle 3 Day 1 (PREDOSE) | QRS Cycle 3 Day 1 (4 H) | QRS Cycle 3 Day 1 (6 H) | QRS Cycle 4 Day 1 (PREDOSE) | QRS Cycle 4 Day 1 (4 H) | QT Duration Baseline | QT Duration Cycle 1 Day 1 (4 H) | QT Duration Cycle 1 Day 1 (6 H) | QT Duration Cycle 1 Day 2 (PREDOSE) | QT Duration Cycle 1 Day 2 (24 H) | QT Duration Cycle 1 Day 5 (PREDOSE) | QT Duration Cycle 1 Day 5 (4 H) | QT Duration Cycle 1 Day 5 (6 H) | QT Duration Cycle 2 Day 1 (PREDOSE) | QT Durations Cycle 3 Day 1 (PREDOSE) | QT Durations Cycle 3 Day 1 (4 H) | QT Durations Cycle 3 Day 1 (6 H) | QT Durations Cycle 4 Day 1 (PREDOSE) | QT Durations Cycle 4 Day 1 (4 H) | QTcB baseline | QTcB - Bazett's Correction Formula Cycle 1 Day 1 (4 H) | QTcB - Bazett's Correction Formula Cycle 1 Day 1 (6 H) | QTcB - Bazett's Correction Formula Cycle 1 Day 2 (PREDOSE) | QTcB - Bazett's Correction Formula Cycle 1 Day 2 (24 H) | QTcB - Bazett's Correction Formula Cycle 1 Day 5 (PREDOSE) | QTcB - Bazett's Correction Formula Cycle 4 Day 1 (4 H) | QTcB - Bazett's Correction FormulaCycle 1 Day 5 (4 H) | QTcB - Bazett's Correction Formula Cycle 1 Day 5 (6 H) | QTcB - Bazett's Correction Formula Cycle 2 Day 1 (PREDOSE) | QTcB - Bazett's Correction Formula Cycle 3 Day 1 (PREDOSE) | QTcB - Bazett's Correction Formula Cycle 3 Day 1 (4 H) | QTcB - Bazett's Correction Formula Cycle 3 Day 1 (6 H) | QTcB - Bazett's Correction Formula Cycle 4 Day 1 (PREDOSE) | QTcB - Bazett's Correction Formula Cycle 4 Day 1, 4 H | QTcF Durations Fridericia's Correction Formula Baseline | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 1 (4 H) | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 1 (6 H) | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 2 (PREDOSE) | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 2 (24 H) | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (PREDOSE) | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (4 H) | QTcF Durations Fridericia's Correction Formula Cycle 1 Day 5 (6 H) | QTcF Durations Fridericia's Correction Formula Cycle 2 Day 1 (PREDOSE) | QTcF Durations Fridericia's Correction Formula Cycle 3 Day 1 (PREDOSE) | QTcF Durations Fridericia's Correction Formula Cycle 3 Day 1 (4 H) | QTcF Durations Fridericia's Correction Formula Cycle 3 Day 1 (6 H) | QTcF Durations Fridericia's Correction Formula Cycle 4 Day 1 (PREDOSE) | QTcF Durations Fridericia's Correction Formula Cycle 4 Day 1 (4 H) | RR Duration Baseline | RR Duration Cycle 1 Day 1 4 H | RR Duration Cycle 1 Day 1 6 H | RR Duration Cycle 1 Day 2 (PREDOSE) | RR Duration Cycle 1 Day 2 (24 H) | RR Duration Cycle 1 Day 5 (PREDOSE) | RR Duration Cycle 1 Day 5 (4 H) | RR Duration Cycle 1 Day 5 (6 H) | RR Duration Cycle 2 Day 1 (PREDOSE) | RR Duration Cycle 3 Day 1 (PREDOSE) | RR Duration Cycle 3 Day 1 (4 H) | RR Duration Cycle 3 Day 1 (6 H) | RR Duration Cycle 4 Day 1 (PREDOSE) | RR Duration Cycle 4 Day 1 (4 H) | |
| Ruxolitinib-naïve Participants With Splenomegaly | 158.93 | 0.60 | -2.80 | -14.00 | 1.93 | -1.00 | -8.00 | -4.77 | 1.43 | -6.00 | -8.00 | -6.00 | -20.00 | -20.00 | 90.87 | -1.47 | -1.27 | -4.00 | 1.07 | 0.13 | -1.08 | -0.92 | 0.64 | -4.00 | -4.00 | -4.00 | -2.00 | -2.00 | 396.67 | -7.33 | -9.40 | -6.00 | -10.21 | -6.20 | -4.31 | -10.31 | 5.00 | -2.00 | -10.00 | -4.00 | -16.00 | -16.00 | 427.67 | 3.80 | 8.00 | -15.00 | 3.71 | -11.07 | -62.00 | -2.92 | -4.54 | 3.93 | -16.00 | 6.00 | 8.00 | -62.00 | -62.00 | 417.93 | -1.27 | 1.00 | -12.00 | -2.36 | -10.47 | -0.08 | -7.85 | 3.36 | -11.00 | 0.00 | 4.00 | -45.00 | -45.00 | 861.47 | -38.87 | -65.67 | 28.00 | -51.50 | 25.87 | -26.23 | -21.46 | 7.14 | 48.00 | -59.00 | -43.00 | 182.00 | 182.00 |
"Single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Day 1, hours 4 and 6, Day 2 pre-dose and 24 Hour, Day 5 pre-dose, 4 and 6 Hour), Cycle 2 (Day 1 pre-dose only), Cycle 3 (Day 1 pre-dose, 4 and 6 Hour), Cycle 4 (Day 1 pre-dose and 4 Hour)
| Intervention | Beats per Minute (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1, Day 1, 4 Hour | Cycle 1, Day 1, 6 Hour | Cycle 1 Day 2, pre-dose | Cycle 1 Day 2, 24 Hour | Cycle 1 Day 5, pre-dose | Cycle 1 Day 5, 4 hour | Cycle 1 Day 5, 6 hour | Cycle 2, Day 1, pre-dose | Cycle 3 Day 1, pre-dose | Cycle 3 Day 1, 4 hour | Cycle 3 Day 1, 6 hour | Cycle 4 Day 1, pre-dose | Cycle 4 Day 1, 4 hour | |
| Ruxolitinib-naïve Participants With Splenomegaly | 71.47 | 4.40 | 6.20 | -3.00 | 4.71 | -1.47 | 2.69 | 2.23 | -1.43 | -5.00 | 7.00 | 5.00 | -16.00 | -16.00 |
"Single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Day 1, hours 4 and 6, Day 2 pre-dose and 24 Hour, Day 5 pre-dose, 4 and 6 Hour), Cycle 2 (Day 1 pre-dose only), Cycle 3 (Day 1 pre-dose, 4 and 6 Hour), Cycle 4 (Day 1 pre-dose and 4 Hour)
| Intervention | Beats per Minute (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1, Day 1, 4 Hour | Cycle 1, Day 1, 6 Hour | Cycle 1 Day 2, 24 Hour | Cycle 1 Day 5, pre-dose | Cycle 1 Day 5, 4 hour | Cycle 1 Day 5, 6 hour | Cycle 2, Day 1, pre-dose | |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 77.00 | -21.00 | -11.00 | -5.00 | -4.00 | 5.00 | 6.00 | -12.00 |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 73.17 | 2.50 | 3.00 | -0.67 | -5.60 | -2.20 | -2.80 | -6.17 |
"Single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Day 1, hours 4 and 6, Day 2 pre-dose and 24 Hour, Day 5 pre-dose, 4 and 6 Hour), Cycle 2 (Day 1 pre-dose only), Cycle 3 (Day 1 pre-dose, 4 and 6 Hour), Cycle 4 (Day 1 pre-dose and 4 Hour)
| Intervention | Beats per Minute (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1, Day 1, 4 Hour | Cycle 1, Day 1, 6 Hour | Cycle 1 Day 2, pre-dose | Cycle 1 Day 2, 24 Hour | Cycle 1 Day 5, pre-dose | Cycle 1 Day 5, 4 hour | Cycle 1 Day 5, 6 hour | Cycle 2, Day 1, pre-dose | |
| Ruxolitinib-naïve Participants Without Splenomegaly | 69.80 | 0.60 | -0.60 | -1.00 | -1.75 | -0.75 | -5.00 | -3.75 | -1.50 |
Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study. (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Degrees Celsius (C) (Mean) | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1 Day 15 | Cycle 1 Day 22 | Cycle 2 Day 1 | Cycle 2 Day 15 | Cycle 3 Day 1 | Cycle 3 Day 15 | Cycle 4 Day 1 | Cycle 5 Day 1 | Cycle 6 Day 1 | Cycle 7 Day 1 | Cycle 8 Day 1 | Cycle 9 Day 1 | Cycle 10 Day 1 | Cycle 11 Day 1 | Cycle 12 Day 1 | Cycle 13 Day 1 | Cycle 14 Day 1 | Cycle 15 Day 1 | Cycle 16 Day 1 | Cycle 17 Day 1 | Final Visit | |
| Ruxolitinib-naïve Participants Without Splenomegaly | 36.40 | 0.42 | 0.04 | 0.05 | 0.18 | 0.13 | -0.03 | -0.17 | -0.10 | -0.10 | -0.20 | -0.05 | 0.05 | 0.30 | -0.20 | 0.30 | -0.70 | -0.10 | -0.30 | -0.80 | 0.60 | 0.26 |
Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study. (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Degrees Celsius (C) (Mean) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1 Day 15 | Cycle 1 Day 22 | Cycle 2 Day 1 | Cycle 2 Day 15 | Cycle 3 Day 1 | Cycle 3 Day 15 | Cycle 4 Day 1 | Cycle 5 Day 1 | Cycle 6 Day 1 | Cycle 7 Day 1 | Cycle 8 Day 1 | Cycle 9 Day 1 | Cycle 10 Day 1 | Cycle 11 Day 1 | Cycle 12 Day 1 | Cycle 13 Day 1 | Cycle 14 Day 1 | Cycle 15 Day 1 | Cycle 16 Day 1 | Cycle 17 Day 1 | Cycle 18 Day 1 | Cycle 19 Day 1 | Cycle 20 Day 1 | Final Visit | |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 36.47 | 0.18 | 0.15 | 0.17 | 0.23 | 0.17 | 0.10 | 0.06 | 0.10 | 0.12 | 0.20 | 0.20 | -0.07 | 0.10 | -0.10 | -0.20 | 0 | -0.30 | -0.40 | -0.10 | 0.00 | -0.20 | 0 | 0 | 0.08 |
Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study. (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Degrees Celsius (C) (Mean) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1 Day 15 | Cycle 1 Day 22 | Cycle 2 Day 1 | Cycle 2 Day 15 | Cycle 3 Day 1 | Cycle 3 Day 15 | Cycle 4 Day 1 | Cycle 5 Day 1 | Cycle 6 Day 1 | Cycle 7 Day 1 | Cycle 8 Day 1 | Cycle 9 Day 1 | Cycle 10 Day 1 | Cycle 11 Day 1 | Cycle 12 Day 1 | Cycle 13 Day 1 | Cycle 14 Day 1 | Cycle 15 Day 1 | Cycle 16 Day 1 | Cycle 17 Day 1 | Cycle 18 Day 1 | Cycle 19 Day 1 | Cycle 20 Day 1 | Cycle 21 Day 1 | Cycle 22 Day 1 | Final Visit | |
| Ruxolitinib-naïve Participants With Splenomegaly | 36.50 | 0.13 | 0.03 | -0.05 | 0.04 | -0.09 | -0.04 | -0.05 | 0.05 | -0.03 | 0.01 | -0.01 | 0.03 | -0.08 | -0.07 | -0.10 | 0.00 | 0.00 | -0.10 | 0.03 | 0.03 | 0.07 | -0.15 | 0.00 | 0 | -0.50 | -0.08 |
Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study. (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Degrees Celsius (C) (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1 Day 15 | Cycle 1 Day 22 | Cycle 2 Day 1 | Cycle 2 Day 15 | Cycle 3 Day 1 | Cycle 3 Day 15 | Cycle 4 Day 1 | Cycle 5 Day 1 | Cycle 6 Day 1 | Cycle 7 Day 1 | Cycle 8 Day 1 | Cycle 9 Day 1 | Cycle 10 Day 1 | Cycle 11 Day 1 | Cycle 12 Day 1 | Cycle 13 Day 1 | Cycle 14 Day 1 | Cycle 15 Day 1 | Cycle 16 Day 1 | Cycle 17 Day 1 | Cycle 18 Day 1 | Cycle 19 Day 1 | Cycle 20 Day 1 | Cycle 21 Day 1 | Cycle 22 Day 1 | Cycle 23 Day 1 | Final Visit | |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 37.10 | -0.30 | -0.50 | -0.60 | -0.30 | 0.10 | -0.20 | -0.50 | -0.80 | -0.40 | -0.60 | -0.30 | -0.40 | -0.60 | -0.40 | -0.70 | -0.70 | -0.70 | -0.50 | -0.50 | -0.80 | -0.80 | -0.50 | -0.50 | -0.40 | -0.70 | -0.80 | -0.50 |
"Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Beats per Minute (Mean) | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1 Day 15 | Cycle 1 Day 22 | Cycle 2 Day 1 | Cycle 2 Day 15 | Cycle 3 Day 1 | Cycle 3 Day 15 | Cycle 4 Day 1 | Cycle 5 Day 1 | Cycle 6 Day 1 | Cycle 7 Day 1 | Cycle 8 Day 1 | Cycle 9 Day 1 | Cycle 10 Day 1 | Cycle 11 Day 1 | Cycle 12, Day 1 | Cycle 13, Day 1 | Cycle 14, Day 1 | Cycle 15 Day 1 | Cycle 16 Day 1 | Cycle 17, Day 1 | Final Visit | |
| Ruxolitinib-naïve Participants Without Splenomegaly | 71.6 | 5.4 | 8.2 | 1.8 | 1.8 | -2.0 | 10.8 | 1.7 | -4.0 | -4.3 | 1.5 | -1.0 | 0.0 | 8.5 | -2.0 | -6.0 | -5.0 | -2.0 | 10.0 | -2.0 | 9.0 | 0.2 |
"Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Beats per Minute (Mean) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1 Day 15 | Cycle 1 Day 22 | Cycle 2 Day 1 | Cycle 2 Day 15 | Cycle 3 Day 1 | Cycle 3 Day 15 | Cycle 4 Day 1 | Cycle 5 Day 1 | Cycle 6 Day 1 | Cycle 7 Day 1 | Cycle 8 Day 1 | Cycle 9 Day 1 | Cycle 10 Day 1 | Cycle 11 Day 1 | Cycle 12, Day 1 | Cycle 13, Day 1 | Cycle 14, Day 1 | Cycle 15 Day 1 | Cycle 16 Day 1 | Cycle 17, Day 1 | Cycle 18, Day 1 | Cycle 19, Day 1 | Cycle 20, Day 1 | Final Visit | |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 76.7 | -0.7 | -5.8 | -9.3 | -5.8 | -4.2 | -2.2 | -6.6 | -3.6 | -1.6 | -1.0 | 0.5 | 0.3 | 2.3 | 2.5 | -1.0 | -1.0 | -4.0 | -2.0 | -2.0 | 1.0 | -3.0 | 6.0 | 4.0 | 0.2 |
"Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Beats per Minute (Mean) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1 Day 15 | Cycle 1 Day 22 | Cycle 2 Day 1 | Cycle 2 Day 15 | Cycle 3 Day 1 | Cycle 3 Day 15 | Cycle 4 Day 1 | Cycle 5 Day 1 | Cycle 6 Day 1 | Cycle 7 Day 1 | Cycle 8 Day 1 | Cycle 9 Day 1 | Cycle 10 Day 1 | Cycle 11 Day 1 | Cycle 12, Day 1 | Cycle 13, Day 1 | Cycle 14, Day 1 | Cycle 15 Day 1 | Cycle 16 Day 1 | Cycle 17, Day 1 | Cycle 18, Day 1 | Cycle 19, Day 1 | Cycle 20, Day 1 | Cycle 21, Day 1 | Cycle 22, Day 1 | Final Visit | |
| Ruxolitinib-naïve Participants With Splenomegaly | 74.7 | 4.5 | 3.9 | -1.1 | 0.1 | -2.8 | -1.2 | 1.0 | 0.6 | 0.4 | 1.4 | -3.9 | -5.4 | -0.3 | -2.5 | -0.2 | -2.8 | -3.8 | -0.8 | -1.3 | -12.7 | -4.3 | -9.0 | -5.0 | 2.0 | -8.0 | -1.7 |
"Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Beats per Minute (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1 Day 15 | Cycle 1 Day 22 | Cycle 2 Day 1 | Cycle 2 Day 15 | Cycle 3 Day 1 | Cycle 3 Day 15 | Cycle 4 Day 1 | Cycle 5 Day 1 | Cycle 6 Day 1 | Cycle 7 Day 1 | Cycle 8 Day 1 | Cycle 9 Day 1 | Cycle 10 Day 1 | Cycle 11 Day 1 | Cycle 12, Day 1 | Cycle 13, Day 1 | Cycle 14, Day 1 | Cycle 15 Day 1 | Cycle 16 Day 1 | Cycle 17, Day 1 | Cycle 18, Day 1 | Cycle 19, Day 1 | Cycle 20, Day 1 | Cycle 21, Day 1 | Cycle 22, Day 1 | Cycle 23, Day 1 | Final Visit | |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 68.0 | 7.0 | 8.0 | 12.0 | 9.0 | 9.0 | 21.0 | 24.0 | 28.0 | 14.0 | 21.0 | 11.0 | 0 | 20.0 | 37.0 | 21.0 | 16.0 | 12.0 | 14.0 | 16.0 | 22.0 | 16.0 | 15.0 | 5.0 | 17.0 | 14 | 19.0 | 16.0 |
"Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Breaths per Minute (Mean) | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1 Day 15 | Cycle 1 Day 22 | Cycle 2 Day 1 | Cycle 2 Day 15 | Cycle 3 Day 1 | Cycle 3 Day 15 | Cycle 4 Day 1 | Cycle 5 Day 1 | Cycle 6 Day 1 | Cycle 7 Day 1 | Cycle 8 Day 1 | Cycle 9 Day 1 | Cycle 10 Day 1 | Cycle 11 Day 1 | Cycle 12 Day 1 | Cycle 13 Day 1 | Cycle 14 Day 1 | Cycle 15 Day 1 | Cycle 16 Day 1 | Cycle 17 Day 1 | Final visit | |
| Ruxolitinib-naïve Participants Without Splenomegaly | 17.4 | -0.2 | 0.2 | -0.3 | 0.0 | -1.5 | 0.0 | -3.3 | -0.3 | -0.5 | 0 | -0.5 | 0.5 | -0.5 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | -1.2 |
"Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Breaths per Minute (Mean) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1 Day 15 | Cycle 1 Day 22 | Cycle 2 Day 1 | Cycle 2 Day 15 | Cycle 3 Day 1 | Cycle 3 Day 15 | Cycle 4 Day 1 | Cycle 5 Day 1 | Cycle 6 Day 1 | Cycle 7 Day 1 | Cycle 8 Day 1 | Cycle 9 Day 1 | Cycle 10 Day 1 | Cycle 11 Day 1 | Cycle 12 Day 1 | Cycle 13 Day 1 | Cycle 14 Day 1 | Cycle 15 Day 1 | Cycle 16 Day 1 | Cycle 17 Day 1 | Cycle 18 Day 1 | Cycle 19 Day 1 | Cycle 20 Day 1 | Final visit | |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 18.2 | -0.2 | -0.5 | -0.4 | -1.2 | -1.8 | -1.0 | -1.0 | 1.0 | -0.6 | -2.3 | -0.8 | -1.7 | -0.3 | -0.5 | 1.5 | -1.0 | 1.0 | -1.0 | -2.0 | -2.0 | -1.0 | -3.0 | -3.0 | -1.8 |
"Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Breaths per Minute (Mean) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1 Day 15 | Cycle 1 Day 22 | Cycle 2 Day 1 | Cycle 2 Day 15 | Cycle 3 Day 1 | Cycle 3 Day 15 | Cycle 4 Day 1 | Cycle 5 Day 1 | Cycle 6 Day 1 | Cycle 7 Day 1 | Cycle 8 Day 1 | Cycle 9 Day 1 | Cycle 10 Day 1 | Cycle 11 Day 1 | Cycle 12 Day 1 | Cycle 13 Day 1 | Cycle 14 Day 1 | Cycle 15 Day 1 | Cycle 16 Day 1 | Cycle 17 Day 1 | Cycle 18 Day 1 | Cycle 19 Day 1 | Cycle 20 Day 1 | Cycle 21 Day 1 | Cycle 22 Day 1 | Final visit | |
| Ruxolitinib-naïve Participants With Splenomegaly | 17.4 | -0.3 | -0.5 | -0.3 | -0.2 | -0.7 | -0.7 | -0.3 | -0.4 | -0.5 | -0.2 | 0.1 | 0.4 | -0.2 | -0.8 | -0.4 | -1.4 | 0.8 | 0.0 | -0.3 | 1.3 | 1.3 | 1.5 | 2.0 | 2.0 | 0.0 | -0.3 |
"Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Breaths per Minute (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1 Day 15 | Cycle 1 Day 22 | Cycle 2 Day 1 | Cycle 2 Day 15 | Cycle 3 Day 1 | Cycle 3 Day 15 | Cycle 4 Day 1 | Cycle 5 Day 1 | Cycle 6 Day 1 | Cycle 7 Day 1 | Cycle 8 Day 1 | Cycle 9 Day 1 | Cycle 10 Day 1 | Cycle 11 Day 1 | Cycle 12 Day 1 | Cycle 13 Day 1 | Cycle 14 Day 1 | Cycle 15 Day 1 | Cycle 16 Day 1 | Cycle 17 Day 1 | Cycle 18 Day 1 | Cycle 19 Day 1 | Cycle 20 Day 1 | Cycle 21 Day 1 | Cycle 22 Day 1 | Cycle 23 Day 1 | Final visit | |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 16.0 | 0 | 0 | 0 | 2.0 | 0 | 0 | 2.0 | 0 | 2.0 | 2.0 | 0 | -2.0 | 0 | 2.0 | 0 | 2.0 | 0 | 0 | 0 | 0 | 2.0 | 2.0 | 2.0 | 0 | 0 | 0 | 0 |
"Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Millimeters of mercury (mmHg) (Mean) | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1, Day 15 | Cycle 1, Days 22 | Cycle 2, Day 1 | Cycle 2 , Day 15 | Cycle 3, Day 1 | Cycle 3, Day 15 | Cycle 4, Day 1 | Cycle 5, Day 1 | Cycle 6 Day 1 | Cycle 7 Day 1 | Cycle 8 Day 1 | Cycle 9 Day 1 | Cycle 10 Day 1 | Cycle 11 Day 1 | Cycle 12 Day 1 | Cycle 13 Day 1 | Cycle 14 Day 1 | Cycle 15 Day 1 | Cycle 16 Day 1 | Cycle 17 Day 1 | Final Visit | |
| Ruxolitinib-naïve Participants Without Splenomegaly | 132.0 | 3.6 | -5.6 | 2.8 | -2.0 | -3.0 | -3.5 | -7.3 | -2.5 | 2.5 | -4.0 | 5.0 | 3.0 | -3.0 | 14.0 | -8.0 | -8.0 | 18.0 | 14.0 | 8.0 | 24.0 | 7.6 |
"Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Millimeters of mercury (mmHg) (Mean) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1, Day 15 | Cycle 1, Days 22 | Cycle 2, Day 1 | Cycle 2 , Day 15 | Cycle 3, Day 1 | Cycle 3, Day 15 | Cycle 4, Day 1 | Cycle 5, Day 1 | Cycle 6 Day 1 | Cycle 7 Day 1 | Cycle 8 Day 1 | Cycle 9 Day 1 | Cycle 10 Day 1 | Cycle 11 Day 1 | Cycle 12 Day 1 | Cycle 13 Day 1 | Cycle 14 Day 1 | Cycle 15 Day 1 | Cycle 16 Day 1 | Cycle 17 Day 1 | Cycle 18 Day 1 | Cycle 19 Day 1 | Cycle 20 Day 1 | Final Visit | |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 122.3 | 3.8 | 4.8 | -4.3 | -7.2 | 7.3 | -3.8 | 9.8 | 3.3 | 8.6 | 10.0 | 14.0 | -4.3 | 11.0 | 11.0 | 6.5 | 8.0 | 3.0 | 4.0 | 9.0 | 7.0 | 9.0 | 9.0 | 9.0 | 12.8 |
"Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Millimeters of mercury (mmHg) (Mean) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1, Day 15 | Cycle 1, Days 22 | Cycle 2, Day 1 | Cycle 2 , Day 15 | Cycle 3, Day 1 | Cycle 3, Day 15 | Cycle 4, Day 1 | Cycle 5, Day 1 | Cycle 6 Day 1 | Cycle 7 Day 1 | Cycle 8 Day 1 | Cycle 9 Day 1 | Cycle 10 Day 1 | Cycle 11 Day 1 | Cycle 12 Day 1 | Cycle 13 Day 1 | Cycle 14 Day 1 | Cycle 15 Day 1 | Cycle 16 Day 1 | Cycle 17 Day 1 | Cycle 18 Day 1 | Cycle 19 Day 1 | Cycle 20 Day 1 | Cycle 21 Day 1 | Cycle 22 Day 1 | Final Visit | |
| Ruxolitinib-naïve Participants With Splenomegaly | 129.3 | 4.4 | 3.3 | 3.0 | 5.2 | 5.5 | 1.2 | 2.2 | 4.2 | 11.2 | 4.7 | 8.8 | 12.6 | 11.8 | 8.5 | 10.8 | 13.4 | 4.4 | 13.6 | 7.5 | 9.3 | 5.7 | 2.5 | 11.5 | -18.0 | 24.0 | 1.3 |
"Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline, Cycle 1 (Days 15 and 22), Cycle 2 and 3 (Days 1 and 15), Each Cycle 4-23 (Day 1 only) and Final Visit
| Intervention | Millimeters of mercury (mmHg) (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Cycle 1, Day 15 | Cycle 1, Days 22 | Cycle 2, Day 1 | Cycle 2 , Day 15 | Cycle 3, Day 1 | Cycle 3, Day 15 | Cycle 4, Day 1 | Cycle 5, Day 1 | Cycle 6 Day 1 | Cycle 7 Day 1 | Cycle 8 Day 1 | Cycle 9 Day 1 | Cycle 10 Day 1 | Cycle 11 Day 1 | Cycle 12 Day 1 | Cycle 13 Day 1 | Cycle 14 Day 1 | Cycle 15 Day 1 | Cycle 16 Day 1 | Cycle 17 Day 1 | Cycle 18 Day 1 | Cycle 19 Day 1 | Cycle 20 Day 1 | Cycle 21 Day 1 | Cycle 22 Day 1 | Cycle 23 Day 1 | Final Visit | |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 106.0 | 5.0 | -5.0 | 10.0 | 30.0 | 0 | 6.0 | 13.0 | 16.0 | 8.0 | 29.0 | 9.0 | 26.0 | 30.0 | 34.0 | 6.0 | 14.0 | 14.0 | 5.0 | 4.0 | 6.0 | 13.0 | 13.0 | 13.0 | 7.0 | 6.0 | 11.0 | 19.0 |
Complete hematologic remission requires all of the following: Hct control without phlebotomy between Week 32 (Cycle 8 Day 28) and Cycle 11 Day 28; WBC count ≤10 × 10^9/L at Cycle 11 Day 28; and Platelet count ≤400 × 10^9/L at Week 32. Hct control is defined as protocol-specified ineligibility for phlebotomy. Eligibility for phlebotomy is defined as a Hct level ≥45% that was ≥3% higher than baseline level or a Hct level of >48% (NCT03287245)
Timeframe: Week 32 (Cycle 8 Day 28), Cycle 11 Day 28
| Intervention | Participants (Number) | |
|---|---|---|
| Cycle 11, Day 28 | Week 32 | |
| Ruxolitinib-naïve Participants With Splenomegaly | 2 | 3 |
| Ruxolitinib-naïve Participants Without Splenomegaly | 1 | 2 |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 0 | 3 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 0 | 0 |
"The ECOG performance status is a scale used to quantify cancer patients' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all pre-disease activities without restriction), 1=Symptomatic but completely ambulatory, 2=Symptomatic, < 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, > 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death.~Only baseline data were collectable. The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline
| Intervention | Percentage of Participant (Number) | |
|---|---|---|
| Baseline 0 | Baseline 1 | |
| Ruxolitinib-naïve Participants With Splenomegaly | 66.7 | 33.3 |
| Ruxolitinib-naïve Participants Without Splenomegaly | 60.0 | 40.0 |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 50.0 | 50.0 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 100.0 | 0 |
"The PGIC is a one-item measure used to assess perceived treatment benefit. Participants were asked Since the start of the treatment you've received in this study, your polycythemia vera (PV) symptoms are: 'very much improved', 'much improved', 'minimally improved', 'no change', 'minimally worse', 'much worse', and 'very much worse'.~The study was pre-maturely terminated by the sponsor's decision, therefore did not reach the end of study." (NCT03287245)
Timeframe: Cycle 2 Day 1, Cycle 3 Day 28, Cycle 5 Day 28, End of Cycle 8 (Week 32), and every 3 cycles thereafter (1 cycle is 28 days) until end of study (up to 2 years)
| Intervention | Count of Participants (Number) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 2, Day 1 Very Much Improved | Cycle 2, Day 1 Much Improved | Cycle 2, Day 1 Minimally Improved | Cycle 2, Day 1 No Change | Cycle 2, Day 1 Minimally Worse | Cycle 2, Day 1 Much Worse | Cycle 2, Day 1 Very Much Worse | Cycle 2, Day 1 Not Assessed | Cycle 3 Day 28 Very Much Improved | Cycle 3 Day 28 Much Improved | Cycle 3 Day 28 Minimally Improved | Cycle 3 Day 28 No Change | Cycle 3 Day 28 Minimally Worse | Cycle 3 Day 28 Much Worse | Cycle 3 Day 28 Very Much Worse | Cycle 3 Day 28 Not Assessed | Cycle 5 Day 28 Very Much Improved | Cycle 5 Day 28 Much Improved | Cycle 5 Day 28 Minimally Improved | Cycle 5 Day 28 No Change | Cycle 5 Day 28 Minimally Worse | Cycle 5 Day 28 Much Worse | Cycle 5 Day 28 Very Much Worse | Cycle 5 Day 28 Not Assessed | Week 32 Very Much Improved | Week 32 Much Improved | Week 32 Minimally Improved | Week 32 No Change | Week 32 Minimally Worse | Week 32 Much Worse | Week 32 Very Much Worse | Week 32 Not Assessed | Cycle 11 Day 28 Very Much Improved | Cycle 11 Day 28 Much Improved | Cycle 11 Day 28 Minimally Improved | Cycle 11 Day 28 No Change | Cycle 11 Day 28 Minimally Worse | Cycle 11 Day 28 Much Worse | Cycle 11 Day 28 Very Much Worse | Cycle 11 Day 28 Not Assessed | Cycle 14 Day 28 Very Much Improved | Cycle 14 Day 28 Much Improved | Cycle 14 Day 28 Minimally Improved | Cycle 14 Day 28 No change | Cycle 14 Day 28 Minimally Worse | Cycle 14 Day 28 Much Worse | Cycle 14 Day 28 Very Much Worse | Cycle 14 Day 28 Not Assessed | Cycle 17 Day 28 Very Much Improved | Cycle 17 Day 28 Much Improved | Cycle 17 Day 28 Minimally Improved | Cycle 17 Day 28 No Change | Cycle 17 Day 28 Minimally Worse | Cycle 17 Day 28 Much Worse | Cycle 17 Day 28 Very Much Worse | Cycle 17 Day 28 Not Assessed | Cycle 20 Day 28 Very Much Improved | Cycle 20 Day 28 Much Improved | Cycle 20 Day 28 Minimally Improved | Cycle 20 Day 28 No Change | Cycle 20 Day 28 Minimally Worse | Cycle 20 Day 28 Much Worse | Cycle 20 Day 28 Very Much Worse | Cycle 20 Day 28 Not Assessed | Final Visit Very Much Improved | Final Visit Much Improved | Final Visit Minimally Improved | Final Visit No Change | Final Visit Minimally Worse | Final Visit Much Worse | Final Visit Very Much Worse | Final Visit Not Assessed | |
| Ruxolitinib-Naïve Participants | 0 | 4 | 5 | 6 | 1 | 0 | 0 | 0 | 4 | 4 | 6 | 3 | 0 | 0 | 0 | 0 | 2 | 6 | 2 | 1 | 0 | 0 | 0 | 4 | 3 | 3 | 3 | 1 | 1 | 0 | 0 | 0 | 1 | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 2 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 2 | 6 | 1 | 0 | 0 | 2 |
| Ruxolitinib-Resistant or Intolerant Participants | 0 | 1 | 3 | 1 | 1 | 0 | 0 | 1 | 1 | 1 | 3 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 1 | 0 | 0 | 0 | 0 | 0 |
"The number of participants with a durable response lasting at least 12 weeks from Week 32 is analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable.~Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: From Week 32 (Cycle 8 Day 28) and at least 12 weeks after until end of study (up to 2 years)
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| HCT Control | Composite Response | ELN Response | Complete Hematologic Response | |
| Ruxolitinib-Naïve Participants With Splenomegaly | 3 | 0 | 4 | 2 |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 3 | 0 | 3 | 2 |
"The number of participants with a durable response lasting at least 12 weeks from Week 32 is analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable.~Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: From Week 32 (Cycle 8 Day 28) and at least 12 weeks after until end of study (up to 2 years)
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| HCT Control | Composite Response | ELN Response | Complete Hematologic Response | |
| Ruxolitinib-Naïve Participants Without Splenomegaly | 2 | 0 | 2 | 2 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 0 | 0 | 0 | 0 |
"The number of participants with a durable response lasting at least 12 weeks from Week 32 is analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable.~Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: From Week 32 (Cycle 8 Day 28) and at least 12 weeks after until end of study (up to 2 years)
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| HCT Control | Composite Response | ELN Response | Complete Hematologic Response | |
| All Ruxolitinib-Naïve Participants | 5 | 0 | 6 | 4 |
| All Ruxolitinib-Resistant or Intolerant Participants | 3 | 0 | 3 | 2 |
"Complete response (CR) includes all of the following: Hct <45% without phlebotomy; Platelet count ≤400 × 10^9/L; WBC count ≤10 × 10^9/L; Normal spleen size on imaging; and No disease-related symptoms. Partial response (PR): in participants who do not fulfill the criteria for CR: Hct <45% without phlebotomy or response in 3 or more of the other criteria. No response (NR): any response that does not satisfy partial response. Progressive disease (PD): increased bone marrow fibrosis from baseline, and/or transformation to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute leukemia.~All responders of each category grouped per timepoint include all categories mentioned above. There were no PD responses at any timepoint.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study." (NCT03287245)
Timeframe: Baseline, Day 28 of Cycles 3, 5, 8, 11, 12, 14, 17, 20 and Final visit (28 days after post-last dose)
| Intervention | Percentage of Participants (Number) | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Complete Response | Baseline Partial Response | Baseline Progressive Disease | Baseline No Response | Cycle 3, Day 28 Complete Response | Cycle 3, Day 28 Partial Response | Cycle 3, Day 28 Progressive Disease | Cycle 3, Day 28 No Response | Cycle 5, Day 28 Complete Response | Cycle 5, Day 28 Partial Response | Cycle 5, Day 28 Progressive Disease | Cycle 5, Day 28 No Response | Cycle 8, Day 28 (Week 32) Complete Response | Cycle 8, Day 28 (Week 32) Partial Response | Cycle 8, Day 28 (Week 32) Progressive Disease | Cycle 8, Day 28 (Week 32) No Response | Cycle 11 Day 28 Complete Response | Cycle 11 Day 28 Partial Response | Cycle 11 Day 28 Progressive Disease | Cycle 11 Day 28 No Response | Cycle 14, Day 28 Complete Response | Cycle 14, Day 28 Partial Response | Cycle 14, Day 28 Progressive Disease | Cycle 14, Day 28 No Response | Cycle 17, Day 28 Complete Response | Cycle 17, Day 28 Partial Response | Cycle 17, Day 28 Progressive Disease | Cycle 17, Day 28 No Response | Cycle 20, Day 28 Complete Response | Cycle 20, Day 28 Partial Response | Cycle 20, Day 28 Progressive Disease | Cycle 20, Day 28 No Response | Final Visit Complete Response | Final Visit Partial Response | Final Visit Progressive Disease | Final Visit No Response | |
| All Ruxolitinib-Naïve Participants | 0 | 0 | 0 | 0 | 10.5 | 68.4 | 0 | 21.1 | 12.5 | 68.8 | 0 | 18.8 | 18.2 | 54.5 | 0 | 27.3 | 16.7 | 66.7 | 0 | 16.7 | 16.7 | 66.7 | 0 | 16.7 | 25.0 | 25.0 | 0 | 50.0 | 0 | 100 | 0 | 0 | 14.3 | 21.4 | 0 | 64.3 |
"Complete response (CR) includes all of the following: Hct <45% without phlebotomy; Platelet count ≤400 × 10^9/L; WBC count ≤10 × 10^9/L; Normal spleen size on imaging; and No disease-related symptoms. Partial response (PR): in participants who do not fulfill the criteria for CR: Hct <45% without phlebotomy or response in 3 or more of the other criteria. No response (NR): any response that does not satisfy partial response. Progressive disease (PD): increased bone marrow fibrosis from baseline, and/or transformation to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute leukemia.~All responders of each category grouped per timepoint include all categories mentioned above. There were no PD responses at any timepoint.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study." (NCT03287245)
Timeframe: Baseline, Day 28 of Cycles 3, 5, 8, 11, 12, 14, 17, 20 and Final visit (28 days after post-last dose)
| Intervention | Percentage of Participants (Number) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Complete Response | Baseline Partial Response | Baseline Progressive Disease | Baseline No Response | Cycle 3, Day 28 Complete Response | Cycle 3, Day 28 Partial Response | Cycle 3, Day 28 Progressive Disease | Cycle 3, Day 28 No Response | Cycle 5, Day 28 Complete Response | Cycle 5, Day 28 Partial Response | Cycle 5, Day 28 Progressive Disease | Cycle 5, Day 28 No Response | Cycle 8, Day 28 (Week 32) Complete Response | Cycle 8, Day 28 (Week 32) Partial Response | Cycle 8, Day 28 (Week 32) Progressive Disease | Cycle 8, Day 28 (Week 32) No Response | Cycle 11 Day 28 Complete Response | Cycle 11 Day 28 Partial Response | Cycle 11 Day 28 Progressive Disease | Cycle 11 Day 28 No Response | Cycle 12 Day 28 Complete Response | Cycle 12 Day 28 Partial Response | Cycle 12 Day 28 Progressive Disease | Cycle 12 Day 28 No Response | Cycle 14, Day 28 Complete Response | Cycle 14, Day 28 Partial Response | Cycle 14, Day 28 Progressive Disease | Cycle 14, Day 28 No Response | Cycle 17, Day 28 Complete Response | Cycle 17, Day 28 Partial Response | Cycle 17, Day 28 Progressive Disease | Cycle 17, Day 28 No Response | Cycle 20, Day 28 Complete Response | Cycle 20, Day 28 Partial Response | Cycle 20, Day 28 Progressive Disease | Cycle 20, Day 28 No Response | Final Visit Complete Response | Final Visit Partial Response | Final Visit Progressive Disease | Final Visit No Response | |
| All Ruxolitinib-Resistant or Intolerant Participants | 0 | 0 | 0 | 0 | 28.6 | 42.9 | 0 | 28.6 | 0 | 66.7 | 0 | 33.3 | 20.0 | 40.0 | 0 | 40.0 | 0 | 50.0 | 0 | 50.0 | 0 | 100 | 0 | 0 | 0 | 50 | 0 | 50.0 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 100 | 0 | 25.0 | 0 | 75.0 |
"The percentage of participants with a durable response lasting at least 12 weeks from Week 32 is analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable.~Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify. The study was pre-maturely terminated by the sponsor decision, therefore did not reach the end of study." (NCT03287245)
Timeframe: From Week 32 (Cycle 8 Day 28) and at least 12 Weeks after until end of study (up to 2 years)
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| After 12 Weeks from Week 32 HCT Control | After 12 Weeks from Week 32 Composite Response | After 12 Weeks from Week 32 ELN Response | After 12 Weeks from Week 32 Complete Hematologic Response | |
| All Ruxolitinib-Naïve Participants | 55.6 | 0 | 60 | 44.4 |
| All Ruxolitinib-Resistant or Intolerant Participants | 75 | 0 | 60 | 50 |
"Complete response (CR) includes all of the following: Hct <45% without phlebotomy; Platelet count ≤400 × 10^9/L; WBC count ≤10 × 10^9/L; Normal spleen size on imaging; and No disease-related symptoms. Partial response (PR): in participants who do not fulfill the criteria for CR: Hct <45% without phlebotomy or response in 3 or more of the other criteria. No response (NR): any response that does not satisfy partial response. Progressive disease (PD): increased bone marrow fibrosis from baseline, and/or transformation to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute leukemia.~All responders of each category grouped per timepoint include all categories mentioned above. There were no PD responses at any timepoint.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study." (NCT03287245)
Timeframe: Baseline, Day 28 of Cycles 3, 5, 8, 11, 12, 14, 17, 20 and Final visit (28 days after post-last dose)
| Intervention | Percentage of Participants (Number) | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Complete Response | Baseline Partial Response | Baseline Progressive Disease | Baseline No Response | Cycle 3, Day 28 Complete Response | Cycle 3, Day 28 Partial Response | Cycle 3, Day 28 Progressive Disease | Cycle 3, Day 28 No Response | Cycle 5, Day 28 Complete Response | Cycle 5, Day 28 Partial Response | Cycle 5, Day 28 Progressive Disease | Cycle 5, Day 28 No Response | Cycle 8, Day 28 (Week 32) Complete Response | Cycle 8, Day 28 (Week 32) Partial Response | Cycle 8, Day 28 (Week 32) Progressive Disease | Cycle 8, Day 28 (Week 32) No Response | Cycle 11, Day 28 Complete Response | Cycle 11, Day 28 Partial Response | Cycle 11, Day 28 Progressive Disease | Cycle 11, Day 28 No Response | Cycle 12, Day 28 Complete Response | Cycle 12, Day 28 Partial Response | Cycle 12, Day 28 Progressive Disease | Cycle 12, Day 28 No Response | Cycle 14, Day 28 Complete Response | Cycle 14, Day 28 Partial Response | Cycle 14, Day 28 Progressive Disease | Cycle 14, Day 28 No Response | Cycle 17, Day 28 Complete Response | Cycle 17, Day 28 Partial Response | Cycle 17, Day 28 Progressive Disease | Cycle 17, Day 28 No Response | Final Visit (28 Days post-last dose) Complete Response | Final Visit (28 Days post-last dose) Partial Response | Final Visit (28 Days post-last dose) Progressive Disease | Final Visit (28 Days post-last dose) No Response | |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 0 | 0 | 0 | 0 | 33.3 | 50.0 | 0 | 16.7 | 0 | 80.0 | 0 | 20.0 | 25.0 | 50.0 | 0 | 25.0 | 0 | 100.0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 0 | 0 | 100 | 0 | 33.3 | 0 | 66.7 |
"Complete response (CR) includes all of the following: Hct <45% without phlebotomy; Platelet count ≤400 × 10^9/L; WBC count ≤10 × 10^9/L; Normal spleen size on imaging; and No disease-related symptoms. Partial response (PR): in participants who do not fulfill the criteria for CR: Hct <45% without phlebotomy or response in 3 or more of the other criteria. No response (NR): any response that does not satisfy partial response. Progressive disease (PD): increased bone marrow fibrosis from baseline, and/or transformation to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute leukemia.~All responders of each category grouped per timepoint include all categories mentioned above. There were no PD responses at any timepoint.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study." (NCT03287245)
Timeframe: Baseline, Day 28 of Cycles 3, 5, 8, 11, 12, 14, 17, 20 and Final visit (28 days after post-last dose)
| Intervention | Percentage of Participants (Number) | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Complete Response | Baseline Partial Response | Baseline Progressive Disease | Baseline No Response | Cycle 3, Day 28 Complete Response | Cycle 3, Day 28 Partial Response | Cycle 3, Day 28 Progressive Disease | Cycle 3, Day 28 No Response | Cycle 5, Day 28 Complete Response | Cycle 5, Day 28 Partial Response | Cycle 5, Day 28 Progressive Disease | Cycle 5, Day 28 No Response | Cycle 8, Day 28 (Week 32) Complete Response | Cycle 8, Day 28 (Week 32) Partial Response | Cycle 8, Day 28 (Week 32) Progressive Disease | Cycle 8, Day 28 (Week 32) No Response | Cycle 11, Day 28 Complete Response | Cycle 11, Day 28 Partial Response | Cycle 11, Day 28 Progressive Disease | Cycle 11, Day 28 No Response | Cycle 14, Day 28 Complete Response | Cycle 14, Day 28 Partial Response | Cycle 14, Day 28 Progressive Disease | Cycle 14, Day 28 No Response | Cycle 17, Day 28 Complete Response | Cycle 17, Day 28 Partial Response | Cycle 17, Day 28 Progressive Disease | Cycle 17, Day 28 No Response | Cycle 20, Day 28 Complete Response | Cycle 20, Day 28 Partial Response | Cycle 20, Day 28 Progressive Disease | Cycle 20, Day 28 No Response | Final Visit (28 Days post-last dose) Complete Response | Final Visit (28 Days post-last dose) Partial Response | Final Visit (28 Days post-last dose) Progressive Disease | Final Visit (28 Days post-last dose) No Response | |
| Ruxolitinib-naïve Participants With Splenomegaly | 0 | 0 | 0 | 0 | 0 | 73.3 | 0 | 26.7 | 0 | 76.9 | 0 | 23.1 | 0 | 66.7 | 0 | 33.3 | 0 | 80.0 | 0 | 20.0 | 0 | 80 | 0 | 20 | 0 | 33.3 | 0 | 66.7 | 0 | 100 | 0 | 0 | 0 | 20.0 | 0 | 80 |
"The percentage of participants with a durable response lasting at least 12 weeks from Week 32 are analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable.~Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify. The study was pre-maturely terminated by the sponsor decision, therefore did not reach the end of study." (NCT03287245)
Timeframe: From Week 32 (Cycle 8 Day 28) and at least 12 Weeks after until end of study (up to 2 years)
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| HCT Control | Composite Response | ELN Response | Complete Hematologic Response | |
| Ruxolitinib-Naïve Participants With Splenomegaly | 42.9 | 0 | 50 | 28.6 |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 100 | 0 | 75 | 66.7 |
"Complete response (CR) includes all of the following: Hct <45% without phlebotomy; Platelet count ≤400 × 10^9/L; WBC count ≤10 × 10^9/L; Normal spleen size on imaging; and No disease-related symptoms. Partial response (PR): in participants who do not fulfill the criteria for CR: Hct <45% without phlebotomy or response in 3 or more of the other criteria. No response (NR): any response that does not satisfy partial response. Progressive disease (PD): increased bone marrow fibrosis from baseline, and/or transformation to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute leukemia.~All responders of each category grouped per timepoint include all categories mentioned above. There were no PD responses at any timepoint.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study." (NCT03287245)
Timeframe: Baseline, Day 28 of Cycles 3, 5, 8, 11, 12, 14, 17, 20 and Final visit (28 days after post-last dose)
| Intervention | Percentage of Participants (Number) | |||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Complete Response | Baseline Partial Response | Baseline Progressive Disease | Baseline No Response | Cycle 3, Day 28 Complete Response | Cycle 3, Day 28 Partial Response | Cycle 3, Day 28 Progressive Disease | Cycle 3, Day 28 No Response | Cycle 5 Day 28 Complete Response | Cycle 5 Day 28 Partial Response | Cycle 5 Day 28 Progressive Disease | Cycle 5 Day 28 No Response | Cycle 8, Day 28 (Week 32) Complete Response | Cycle 8, Day 28 (Week 32) Partial Response | Cycle 8, Day 28 (Week 32) Progressive Disease | Cycle 8, Day 28 (Week 32) No Response | Cycle 11, day 28 Complete Response | Cycle 11, day 28 Partial Response | Cycle 11, day 28 Progressive Disease | Cycle 11, day 28 No Response | Cycle 14, Day 28 Complete Response | Cycle 14, Day 28 Partial Response | Cycle 14, Day 28 Progressive Disease | Cycle 14, Day 28 No Response | Cycle 17, Day 28 Complete Response | Cycle 17, Day 28 Partial Response | Cycle 17, Day 28 Progressive Disease | Cycle 17, Day 28 No Response | Final (28 Days post-last dose) Complete Response | Final (28 Days post-last dose) Partial Response | Final (28 Days post-last dose) Progressive Disease | Final (28 Days post-last dose) No Response | |
| Ruxolitinib-naïve Participants Without Splenomegaly | 0 | 0 | 0 | 0 | 50 | 50 | 0 | 0 | 66.7 | 33.3 | 0 | 0 | 100 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 50.0 | 25.0 | 0.0 | 25.0 |
"Complete response (CR) includes all of the following: Hct <45% without phlebotomy; Platelet count ≤400 × 10^9/L; WBC count ≤10 × 10^9/L; Normal spleen size on imaging; and No disease-related symptoms. Partial response (PR): in participants who do not fulfill the criteria for CR: Hct <45% without phlebotomy or response in 3 or more of the other criteria. No response (NR): any response that does not satisfy partial response. Progressive disease (PD): increased bone marrow fibrosis from baseline, and/or transformation to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute leukemia.~All responders of each category grouped per timepoint include all categories mentioned above. There were no PD responses at any timepoint.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the end of study." (NCT03287245)
Timeframe: Baseline, Day 28 of Cycles 3, 5, 8, 11, 12, 14, 17, 20 and Final visit (28 days after post-last dose)
| Intervention | Percentage of Participants (Number) | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Complete Response | Baseline Partial Response | Baseline Progressive Disease | Baseline No Response | Cycle 3, Day 28 Complete Response | Cycle 3, Day 28 Partial Response | Cycle 3, Day 28 Progressive Disease | Cycle 3, Day 28 No Response | Cycle 5 Day 28 Complete Response | Cycle 5 Day 28 Partial Response | Cycle 5 Day 28 Progressive Disease | Cycle 5 Day 28 No Response | Cycle 8, Day 28 (Week 32) Complete Response | Cycle 8, Day 28 (Week 32) Partial Response | Cycle 8, Day 28 (Week 32) Progressive Disease | Cycle 8, Day 28 (Week 32) No Response | Cycle 11, day 28 Complete Response | Cycle 11, day 28 Partial Response | Cycle 11, day 28 Progressive Disease | Cycle 11, day 28 No Response | Cycle 14, Day 28 Complete Response | Cycle 14, Day 28 Partial Response | Cycle 14, Day 28 Progressive Disease | Cycle 14, Day 28 No Response | Cycle 17, Day 28 Complete Response | Cycle 17, Day 28 Partial Response | Cycle 17, Day 28 Progressive Disease | Cycle 17, Day 28 No Response | Cycle 20, Day 28 Complete Response | Cycle 20, Day 28 Partial Response | Cycle 20, Day 28 Progressive Disease | Cycle 20, Day 28 No Response | Final (28 Days post-last dose) Complete Response | Final (28 Days post-last dose) Partial Response | Final (28 Days post-last dose) Progressive Disease | Final (28 Days post-last dose) No Response | |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 100 |
"The percentage of participants with a durable response lasting at least 12 weeks from Week 32 is analyzed by the type of response achieved: Hct control, complete hematologic response, ELN 2009 response criteria, and composite response, if applicable.~Reported result data start from Cycle 11 Day 28 which is 12 weeks after Week 32 (Cycle 8 Day 28). There was one timepoint for which the participants qualify. The study was pre-maturely terminated by the sponsor decision, therefore did not reach the end of study." (NCT03287245)
Timeframe: From Week 32 (Cycle 8 Day 28) and at least 12 Weeks after until end of study (up to 2 years)
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| HCT Control | Composite Response | ELN Response | Complete Hematologic Response | |
| Ruxolitinib-Naïve Participants Without Splenomegaly | 100 | 0 | 100 | 100 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 0 | 0 | 0 | 0 |
"An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. The adverse event severity grading scale for the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0) will be used for assessing adverse event severity.~During the final analyses, the focus was on the Adverse Events of severity grades >/=3 as shown below. The extensive listings of all grade AEs are available at request.~The study was pre-maturely terminated by the sponsor's decision due to non-transformative efficacy and poor long-term tolerability of the dosing schedule as well as due to chronic gastrointestinal toxicity, therefore did not reach the planned end of study." (NCT03287245)
Timeframe: Baseline to end of study (up to 2 years)
| Intervention | Participants (Number) | |
|---|---|---|
| Baseline | Grade 3-5 AE | |
| Ruxolitinib-Naïve Participants With Splenomegaly | 0 | 5 |
| Ruxolitinib-Naïve Participants Without Splenomegaly | 0 | 2 |
| Ruxolitinib-Resistant or Intolerant Participants With Splenomegaly | 0 | 3 |
| Ruxolitinib-Resistant or Intolerant Participants Without Splenomegaly | 0 | 0 |
Change in the Total Symptom Score which assessed improvement in disease symptoms measured by the change in TSS from the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) instrument being used in this study from baseline to 12 months. This 19 item instrument includes the previously validated 9 item brief fatigue inventory (BFI), symptoms related to splenomegaly, inactivity, cough, night sweats, pruritus, bone pains, fevers, weight loss, and an overall quality of life assessment. Each item is scored from 0-10 with full scale from 0-190, with higher scores mean worse symptoms. (NCT01259856)
Timeframe: baseline and 12 months
| Intervention | score on a scale (Mean) |
|---|---|
| PEGASYS | 1.16 |
| Hydroxyurea | -1.0 |
(NCT01259856)
Timeframe: 4 years
| Intervention | Participants (Count of Participants) |
|---|---|
| PEGASYS | 1 |
| Hydroxyurea | 1 |
Number of participants with Complete Remission after 12 months of therapy assessed by hematologic response rates two strata of patients with high risk polycythemia vera (PV) or high risk essential thrombocythemia (ET). Complete remission means no evidence of disease. (NCT01259856)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Essential Thrombocythemia | Polycythemia Vera | |
| Hydroxyurea | 19 | 13 |
| PEGASYS | 17 | 12 |
Number of Participants with Grade 3 and Grade 4 Hematological and Non-hematological Events using the Common Terminology Criteria for Adverse Events (CTCAE) 4.0 to assess the toxicity, safety and tolerability of therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea). (NCT01259856)
Timeframe: 4 years
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Grade 3 Hematological event | Grade 4 Hematological event | Grade 3 Non-hematological event | Grade 4 Non-hematological event | |
| Hydroxyurea | 2 | 0 | 14 | 3 |
| PEGASYS | 3 | 0 | 27 | 2 |
Number of participants with Partial Remission after 12 months of therapy assessed by hematologic response rates two strata of patients with high risk polycythemia vera (PV) or high risk essential thrombocythemia (ET). Partial Remission means decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. (NCT01259856)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Essential Thrombocythemia | Polycythemia Vera | |
| Hydroxyurea | 11 | 17 |
| PEGASYS | 10 | 25 |
"Survival and incidence of development of myelodysplastic syndrome, myelofibrosis, or leukemic transformation after therapy~To estimate survival and incidence of development of myelodysplastic syndrome, myelofibrosis, or leukemic transformation after therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea) by capturing the rate of progression to a more advanced myeloid malignancy." (NCT01259856)
Timeframe: 4 years
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Death | Progression to MF | |
| Hydroxyurea | 1 | 0 |
| PEGASYS | 0 | 0 |
"Proportion of patients achieving a complete hematological remission at Week 28 was defined by:~Hct control at Week 28 defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 28, with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and~WBC < 10 x109/L at Week 28, and~Platelets ≤ 400 x 109/L at Week 28" (NCT02038036)
Timeframe: Week 28
| Intervention | Participants (Count of Participants) |
|---|---|
| Ruxolitinib | 17 |
| Best Available Therapy (BAT) | 4 |
"Proportion of patients achieving a partial remission at Week 28, based on the ELN and IWG-MRT criteria, as defined by:~Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) score reduction of greater than or equal to 10 points from baseline to Week 28, and~Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 28, with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and~WBC < 10 x10^9/L at Week 28, and~Platelets ≤ 400 x 10^9/L at Week 28, and~No palpable spleen at Week 28, and~No hemorrhagic or thrombotic events, and~No transformation into post-PV myelofibrosis, myelodysplastic syndrome (IWG-MRT criteria) or acute leukemia (WHO criteria)." (NCT02038036)
Timeframe: Week 28
| Intervention | Participants (Count of Participants) |
|---|---|
| Ruxolitinib | 7 |
| Best Available Therapy (BAT) | 0 |
"Proportion of patients achieving Hct control at Week 28 was defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 28, with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8.~Phlebotomy eligibility was defined by:~Confirmed Hct > 45% that is at least 3 percentage points higher than the Hct obtained at Baseline Or~Confirmed Hct > 48% The confirmation occurred 2 to 14 days subsequent to the initial observation." (NCT02038036)
Timeframe: Week 28
| Intervention | Participants (Count of Participants) |
|---|---|
| Ruxolitinib | 46 |
| Best Available Therapy (BAT) | 14 |
Proportion of participants developing any arterial or venous thromboembolic event (NCT02038036)
Timeframe: From randomization to Week 80 for BAT and Week 260 for Ruxolitinib
| Intervention | Participants (Count of Participants) |
|---|---|
| Ruxolitinib | 0 |
| Best Available Therapy (BAT) | 0 |
Overall survival (OS) event is defined as death due to any cause. OS events were counted in the BAT arm, irrespective of whether participants crossed over to receive ruxolitinib when the event occurred. (NCT02038036)
Timeframe: up to Week 260
| Intervention | Participants (Count of Participants) |
|---|---|
| Ruxolitinib | 3 |
| Best Available Therapy (BAT) | 6 |
"Transformation-free survival is defined as one of the following:~Myelofibrosis (MF) as evidenced by bone marrow biopsy, or~Acute leukemia as evidenced by bone marrow blast counts of at least 20%, or peripheral blast counts of at least 20% lasting at least 2 weeks.~Death due to any cause during treatment period" (NCT02038036)
Timeframe: Week 260 (ruxolitinib arm) and Week 80 (BAT arm)
| Intervention | Participants (Count of Participants) |
|---|---|
| Ruxolitinib | 4 |
| Best Available Therapy (BAT) | 3 |
EQ-5D-5L is a standardized instrument for measuring health outcomes in a wide range of health conditions and treatments. It consists of visual analogue scale (EQ VAS) which records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled 'Best imaginable health state' and 'worst imaginable health state'. The EQ VAS scores were anchored on 100 = the best health you can imagine and 0 = worst health you can imagine. (NCT02038036)
Timeframe: Baseline (last assessment before cross over), Week 4, 8, 16, 24, 28, 52, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247 after cross-over
| Intervention | Score on a scale (Mean) | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week +4 | Week +8 | Week +16 | Week +24 | Week +28 | Week +52 | Week 92 | Week 104 | Week 117 | Week 130 | Week 143 | Week 156 | Week 169 | Week 182 | Week 195 | Week 208 | Week 221 | Week 234 | Week 247 | |
| Best Available Therapy (BAT) | 4.54 | 4.62 | 6.58 | 6.38 | 5.26 | 4.71 | 8.09 | 6.48 | 4.92 | 4.87 | 3.19 | 2.65 | 4.59 | 2.71 | 5.65 | 5.35 | 7.71 | 5.30 | 4.14 |
Hematocrit is the percentage of red blood cells (RBC) in the blood. (NCT02038036)
Timeframe: Baseline (last assessment before cross over), Week 4, 8, 12, 16, 20, 24, 28, 40, 52, 64, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206, 219 and 232 after cross-over
| Intervention | Volume percentage of RBC in blood (Mean) | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week +4 | Week +8 | Week +12 | Week +16 | Week +20 | Week +24 | Week +28 | Week +40 | Week +52 | Week +64 | Week +76 | Week +89 | Week +102 | Week +115 | Week +128 | Week +141 | Week +154 | Week +167 | Week +180 | Week +193 | Week +206 | Week +219 | Week +232 | |
| All Crossover Patients | -2.44 | -4.24 | -5.73 | -6.27 | -5.76 | -5.29 | -6.04 | -6.06 | -5.91 | -7.06 | -6.16 | -6.79 | -6.21 | -7.04 | -7.41 | -7.00 | -7.06 | -7.44 | -7.51 | -7.16 | -7.09 | -6.95 | -7.51 |
Hematocrit is the volume percentage of red blood cells (RBC) in the blood. (NCT02038036)
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 40, 52, 66, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234, 247 and 260
| Intervention | volume percentage of RBC in blood (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 40 | Week 52 | Week 66 | Week 80 | |
| Best Available Therapy (BAT) | 1.25 | 1.63 | 1.70 | 1.83 | 1.45 | 1.52 | 2.09 | 2.05 | 1.68 | 2.73 | 0.62 |
Hematocrit is the volume percentage of red blood cells (RBC) in the blood. (NCT02038036)
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 40, 52, 66, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234, 247 and 260
| Intervention | volume percentage of RBC in blood (Mean) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 40 | Week 52 | Week 66 | Week 80 | Week 92 | Week 104 | Week 117 | Week 130 | Week 143 | Week 156 | Week 169 | Week 182 | Week 195 | Week 208 | Week 221 | Week 234 | Week 247 | Week 260 | |
| Ruxolitinib | -0.65 | -1.22 | -2.33 | -3.25 | -3.05 | -2.85 | -2.60 | -2.77 | -2.49 | -3.06 | -3.20 | -2.91 | -3.19 | -2.86 | -3.13 | -3.50 | -3.54 | -3.57 | -2.94 | -3.36 | -3.23 | -3.55 | -3.31 | -3.45 | -2.93 |
The MPN-SAF TSS is a disease specific questionnaire comprised of 10 items that measures fatigue related to MPN disease and the severity of nine of the most prevalent associated symptoms. Each item is scored on a scale ranging from 0 (no fatigue/absent) to 10 (As bad as you can imagine/worst imaginable).The MPN-SAF TSS is computed as the average of the observed items multiplied by 10 to achieve a 0-to-100 scale. The MPN-SAF TSS thus has a possible score range of 0 to 100 where a decrease indicates improvement. (NCT02038036)
Timeframe: Baseline, Week 4, 8, 16, 28, 40, 52, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247
| Intervention | Score on a scale (Mean) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 4 | Week 8 | Week 16 | Week 28 | Week 40 | Week 52 | Week 80 | Week 92 | Week 104 | Week 117 | Week 130 | Week 143 | Week 156 | Week 169 | Week 182 | Week 195 | Week 208 | Week 221 | Week 234 | Week 247 | |
| Ruxolitinib | -8.43 | -9.86 | -9.14 | -10.29 | -9.35 | -8.63 | -9.04 | -7.69 | -6.82 | -6.76 | -8.26 | -8.56 | -8.48 | -7.65 | -9.34 | -7.57 | -9.26 | -7.20 | -7.50 | -7.82 |
The MPN-SAF TSS is a disease specific questionnaire comprised of 10 items that measures fatigue related to MPN disease and the severity of nine of the most prevalent associated symptoms. Each item is scored on a scale ranging from 0 (no fatigue/absent) to 10 (As bad as you can imagine/worst imaginable).The MPN-SAF TSS is computed as the average of the observed items multiplied by 10 to achieve a 0-to-100 scale. The MPN-SAF TSS thus has a possible score range of 0 to 100 where a decrease indicates improvement. (NCT02038036)
Timeframe: Baseline, Week 4, 8, 16, 28, 40, 52, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247
| Intervention | Score on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Week 4 | Week 8 | Week 16 | Week 28 | Week 40 | Week 52 | |
| Best Available Therapy (BAT) | 0.40 | 1.37 | 1.41 | 2.34 | 0.10 | 0.63 |
EQ-5D-5L is a standardized instrument for measuring health outcomes in a wide range of health conditions and treatments. It consists of visual analogue scale (EQ VAS) which records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled 'Best imaginable health state' and 'worst imaginable health state'. The EQ VAS scores were anchored on 100 = the best health you can imagine and 0 = worst health you can imagine. (NCT02038036)
Timeframe: Baseline, Week 4, 8, 16, 28, 52, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247
| Intervention | Score on a scale (Mean) | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 4 | Week 8 | Week 16 | Week 28 | Week 52 | Week 80 | Week 92 | Week 104 | Week 117 | Week 130 | Week 143 | Week 156 | Week 169 | Week 182 | Week 195 | Week 208 | Week 221 | Week 234 | Week 247 | |
| Ruxolitinib | 4.24 | 7.62 | 6.35 | 7.56 | 7.36 | 4.50 | 6.77 | 6.25 | 6.42 | 7.70 | 5.68 | 4.74 | 6.08 | 7.68 | 6.41 | 7.94 | 3.64 | 5.48 | 6.28 |
EQ-5D-5L is a standardized instrument for measuring health outcomes in a wide range of health conditions and treatments. It consists of visual analogue scale (EQ VAS) which records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled 'Best imaginable health state' and 'worst imaginable health state'. The EQ VAS scores were anchored on 100 = the best health you can imagine and 0 = worst health you can imagine. (NCT02038036)
Timeframe: Baseline, Week 4, 8, 16, 28, 52, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247
| Intervention | Score on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Week 4 | Week 8 | Week 16 | Week 28 | Week 52 | |
| Best Available Therapy (BAT) | 0.04 | -2.73 | -3.12 | 0.16 | 2.50 |
The MPN-SAF TSS is a disease specific questionnaire comprised of 10 items that measures fatigue related to MPN disease and the severity of nine of the most prevalent associated symptoms. Each item is scored on a scale ranging from 0 (no fatigue/absent) to 10 (As bad as you can imagine/worst imaginable).The MPN-SAF TSS is computed as the average of the observed items multiplied by 10 to achieve a 0-to-100 scale. The MPN-SAF TSS thus has a possible score range of 0 to 100 where a decrease indicates improvement. (NCT02038036)
Timeframe: Baseline (last assessment before cross over), Week 4, 8, 16, 24, 28, 40, 52, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247 after cross-over
| Intervention | Score on a scale (Mean) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week +4 | Week +8 | Week +16 | Week +24 | Week +28 | Week +40 | Week +52 | Week 92 | Week 104 | Week 117 | Week 130 | Week 143 | Week 156 | Week 169 | Week 182 | Week 195 | Week 208 | Week 221 | Week 234 | Week 247 | |
| Best Available Therapy (BAT) | -8.00 | -9.76 | -9.40 | -9.15 | -8.46 | -8.58 | -7.15 | -10.49 | -8.08 | -9.01 | -10.18 | -8.36 | -9.54 | -11.15 | -10.13 | -10.88 | -9.43 | -10.02 | -8.01 | -9.84 |
"The Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) is a six item questionnaire which intended to measure work and activity impairment associated with polycythemia vera. WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the polycythemia vera; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the polycythemia vera on productivity while working; Q6=Impact of the polycythemia vera on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. Scores were multiplied by 100 to express in percentages.~Percent work time missed due to problem (past 7 days) =Q2/(Q2+Q4) Percent impairment while working due to problem (past 7 days): Q5/10 Percent overall work impairment due to problem (past 7 says): Q2/(Q2+Q4)+[(1 Q2/(Q2+Q4))x(Q5/10)] Percent activity impairment due to problem (past 7 says): Q6/10" (NCT02038036)
Timeframe: Baseline, Week 4, 8, 16, 28, 52 and 80
| Intervention | Percent (Mean) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Percent work time missed due to problem (past 7 days) Week 4 | Percent work time missed due to problem (past 7 days) Week 8 | Percent work time missed due to problem (past 7 days) Week 16 | Percent work time missed due to problem (past 7 days) Week 28 | Percent work time missed due to problem (past 7 days) Week 52 | Percent impairment while working due to problem (past 7 days) Week 4 | Percent impairment while working due to problem (past 7 days) Week 8 | Percent impairment while working due to problem (past 7 days) Week 16 | Percent impairment while working due to problem (past 7 days) Week 28 | Percent impairment while working due to problem (past 7 days) Week 52 | Percent overall work impairment due to problem (past 7 days) Week 4 | Percent overall work impairment due to problem (past 7 days) Week 8 | Percent overall work impairment due to problem (past 7 days) Week 16 | Percent overall work impairment due to problem (past 7 days) Week 28 | Percent overall work impairment due to problem (past 7 days) Week 52 | Percent activity impairment due to problem (past 7 days) Week 4 | Percent activity impairment due to problem (past 7 days) Week 8 | Percent activity impairment due to problem (past 7 days) Week 16 | Percent activity impairment due to problem (past 7 days) Week 28 | Percent activity impairment due to problem (past 7 days) Week 52 | |
| Best Available Therapy (BAT) | -0.40 | -4.35 | 4.79 | -2.19 | -8.33 | 0.00 | -0.59 | 4.12 | -10.00 | -20.00 | -2.34 | -4.38 | 5.34 | -8.85 | -22.50 | 2.42 | 1.97 | 0.65 | 2.73 | 0.00 |
"The Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) is a six item questionnaire which intended to measure work and activity impairment associated with polycythemia vera. WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the polycythemia vera; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the polycythemia vera on productivity while working; Q6=Impact of the polycythemia vera on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. Scores were multiplied by 100 to express in percentages.~Percent work time missed due to problem (past 7 days) =Q2/(Q2+Q4) Percent impairment while working due to problem (past 7 days): Q5/10 Percent overall work impairment due to problem (past 7 says): Q2/(Q2+Q4)+[(1 Q2/(Q2+Q4))x(Q5/10)] Percent activity impairment due to problem (past 7 says): Q6/10" (NCT02038036)
Timeframe: Baseline, Week 4, 8, 16, 28, 52 and 80
| Intervention | Percent (Mean) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Percent work time missed due to problem (past 7 days) Week 4 | Percent work time missed due to problem (past 7 days) Week 8 | Percent work time missed due to problem (past 7 days) Week 16 | Percent work time missed due to problem (past 7 days) Week 28 | Percent work time missed due to problem (past 7 days) Week 52 | Percent work time missed due to problem (past 7 days) Week 80 | Percent impairment while working due to problem (past 7 days) Week 4 | Percent impairment while working due to problem (past 7 days) Week 8 | Percent impairment while working due to problem (past 7 days) Week 16 | Percent impairment while working due to problem (past 7 days) Week 28 | Percent impairment while working due to problem (past 7 days) Week 52 | Percent impairment while working due to problem (past 7 days) Week 80 | Percent overall work impairment due to problem (past 7 days) Week 4 | Percent overall work impairment due to problem (past 7 days) Week 8 | Percent overall work impairment due to problem (past 7 days) Week 16 | Percent overall work impairment due to problem (past 7 days) Week 28 | Percent overall work impairment due to problem (past 7 days) Week 52 | Percent overall work impairment due to problem (past 7 days) Week 80 | Percent activity impairment due to problem (past 7 days) Week 4 | Percent activity impairment due to problem (past 7 days) Week 8 | Percent activity impairment due to problem (past 7 days) Week 16 | Percent activity impairment due to problem (past 7 days) Week 28 | Percent activity impairment due to problem (past 7 days) Week 52 | Percent activity impairment due to problem (past 7 days) Week 80 | |
| Ruxolitinib | -5.50 | -4.88 | 4.50 | -5.85 | -2.82 | 1.87 | -6.67 | -13.16 | -14.00 | -14.29 | -10.00 | -14.76 | -9.63 | -11.32 | -10.26 | -15.98 | -12.61 | -14.36 | -11.97 | -11.58 | -14.36 | -11.67 | -11.23 | -11.09 |
"The Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) is a six item questionnaire which intended to measure work and activity impairment associated with polycythemia vera. WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the polycythemia vera; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the polycythemia vera on productivity while working; Q6=Impact of the polycythemia vera on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. Scores were multiplied by 100 to express in percentages.~Percent work time missed due to problem (past 7 days) =Q2/(Q2+Q4) Percent impairment while working due to problem (past 7 days): Q5/10 Percent overall work impairment due to problem (past 7 says): Q2/(Q2+Q4)+[(1 Q2/(Q2+Q4))x(Q5/10)] Percent activity impairment due to problem (past 7 says): Q6/10" (NCT02038036)
Timeframe: Baseline (last assessment before cross over), Week 4, 8, 16, 24, 28 and 52 after cross-over
| Intervention | Percent (Mean) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Percent work time missed due to problem (past 7 days) Week +4 | Percent work time missed due to problem (past 7 days) Week +8 | Percent work time missed due to problem (past 7 days) Week +16 | Percent work time missed due to problem (past 7 days) Week +24 | Percent work time missed due to problem (past 7 days) Week +28 | Percent work time missed due to problem (past 7 days) Week +52 | Percent impairment while working due to problem (past 7 days) Week +4 | Percent impairment while working due to problem (past 7 days) Week +8 | Percent impairment while working due to problem (past 7 days) Week +16 | Percent impairment while working due to problem (past 7 days) Week +24 | Percent impairment while working due to problem (past 7 days) Week +28 | Percent impairment while working due to problem (past 7 days) Week +52 | Percent overall work impairment due to problem (past 7 days) Week +4 | Percent overall work impairment due to problem (past 7 days) Week +8 | Percent overall work impairment due to problem (past 7 days) Week +16 | Percent overall work impairment due to problem (past 7 days) Week +24 | Percent overall work impairment due to problem (past 7 days) Week +28 | Percent overall work impairment due to problem (past 7 days) Week +52 | Percent activity impairment due to problem (past 7 days) Week +4 | Percent activity impairment due to problem (past 7 days) Week +8 | Percent activity impairment due to problem (past 7 days) Week +16 | Percent activity impairment due to problem (past 7 days) Week +24 | Percent activity impairment due to problem (past 7 days) Week +28 | Percent activity impairment due to problem (past 7 days) Week +52 | |
| Best Available Therapy (BAT) | -7.45 | -3.90 | -2.66 | -1.67 | 7.06 | 1.12 | -5.33 | -4.29 | -10.83 | -6.92 | -3.33 | -6.00 | -10.98 | -6.91 | -4.73 | -6.06 | -1.81 | -4.03 | -10.43 | -8.63 | -8.82 | -6.47 | -6.94 | -7.00 |
"Proportion of patients achieving a complete hematological remission at Week 104 as defined by Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 104, with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and~WBC < 10 x10^9/L at Week 104, and~Platelets ≤ 400 x 10^9/L at Week 104 Endpoint for Week 156, Week 208 and Week 260 were defined, similarly." (NCT02038036)
Timeframe: From Week 8 to Week 104, 156, 208 and 260
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Week 104 | Week 156 | Week 208 | Week 260 | |
| Ruxolitinib | 15 | 19 | 11 | 9 |
"Proportion of patients achieving a complete hematological remission at Week 52, was defined by:~Hct control at Week 52, as defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 52 with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and~White Blood Count (WBC) < 10 x10^9/L at Week 52, and~Platelets ≤ 400 x 10^9/L at Week 52~Endpoint for Week 80 was defined, similarly." (NCT02038036)
Timeframe: Week 52 and 80
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Week 52 | Week 80 | |
| Best Available Therapy (BAT) | 3 | 2 |
| Ruxolitinib | 17 | 18 |
"Proportion of patients achieving a Hct control at Week 52 was defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 52, and no more than one phlebotomy eligibility occurring post randomization and prior to Week 8~- Endpoint for Week 80 was defined, similarly." (NCT02038036)
Timeframe: Week 52 and 80
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Week 52 | Week 80 | |
| Best Available Therapy (BAT) | 5 | 2 |
| Ruxolitinib | 44 | 35 |
"Proportion of patients who achieved partial remission at Week 104, based on the ELN and IWG-MRT criteria, as defined by:~MPN-SAF TSS score reduction of greater than or equal to 10 points from baseline to Week 104, and~Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 104, with no more than one phlebotomy eligibility occurring post-randomization and prior to Week 8, and~WBC < 10 x10^9/L at Week 104, and~Platelets ≤ 400 x 10^9/L at Week 104, and~No palpable spleen at Week 104, and~No hemorrhagic or thrombotic events, and~No transformation into post-PV myelofibrosis, myelodysplastic syndrome (IWG-MRT criteria) or acute leukemia (WHO criteria) Endpoint for Week 156, Week 208 and Week 260 are defined, similarly." (NCT02038036)
Timeframe: From Week 8 to Week 104, 156, 208 and 260
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Week 104 | Week 156 | Week 208 | Week 260 | |
| Ruxolitinib | 4 | 9 | 4 | 0 |
"Proportion of patients who achieved partial remission at Week 52 based on the ELN and IWG-MRT criteria, as defined by:~MPN-SAF TSS score reduction of greater than or equal to 10 points from baseline to Week 52 and~Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 52 with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and~WBC < 10 x109/L at Week 52 and~Platelets ≤ 400 x 109/L at Week 52 and~No palpable spleen at Week 52 and~No hemorrhagic or thrombotic events, and~No transformation into post-PV myelofibrosis, myelodysplastic syndrome (IWG-MRT criteria) or acute leukemia (WHO criteria).~Endpoint for Week 80 was defined, similarly." (NCT02038036)
Timeframe: Week 52 and 80
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Week 52 | Week 80 | |
| Best Available Therapy (BAT) | 0 | 0 |
| Ruxolitinib | 5 | 4 |
Phlebotomy eligibility was defined by Confirmed Hct > 45% that is at least 3 percentage points higher than the Hct obtained at Baseline Or Confirmed Hct > 48%. The confirmation occurred 2 to 14 days subsequent to the initial observation. (NCT02038036)
Timeframe: Baseline to Week 260
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Phlebotomy frequency: >0 - <=2 | Phlebotomy frequency: >2 - <=4 | Phlebotomy frequency: >4 - <=6 | Phlebotomy frequency: >6 - <=8 | |
| Best Available Therapy (BAT) | 29 | 17 | 2 | 1 |
| Ruxolitinib | 12 | 7 | 4 | 0 |
Spleen length was assessed by manual palpation at every study visit. (NCT02038036)
Timeframe: Week 4, 8, 12, 16, 20, 24, 28, 40, 52, 66, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234, 247 and 260
| Intervention | cm (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 40 | Week 52 | Week 66 | Week 80 | |
| Best Available Therapy (BAT) | 0.04 | 0.01 | 0.01 | 0.23 | 0.13 | 0.09 | 0.20 | 0.52 | 0.07 | 0.00 | 0.00 |
Spleen length was assessed by manual palpation at every study visit. (NCT02038036)
Timeframe: Week 4, 8, 12, 16, 20, 24, 28, 40, 52, 66, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234, 247 and 260
| Intervention | cm (Mean) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 40 | Week 52 | Week 66 | Week 80 | Week 92 | Week 104 | Week 117 | Week 130 | Week 143 | Week 156 | Week 169 | Week 182 | Week 195 | Week 208 | Week 221 | Week 234 | Week 247 | Week 260 | |
| Ruxolitinib | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.01 | 0.06 | 0.00 | 0.03 | 0.00 | 0.05 | 0.12 | 0.18 | 0.08 | 0.05 | 0.05 | 0.05 | 0.00 | 0.00 | 0.02 | 0.00 | 0.02 | 0.10 |
On-treatment deaths were reported from the day of first dose of study medication to the End of study (End of Treatment +30 days) visit which was Week 260 or prior (+30 days for Rux + crossover) and Week 80 or prior (+30 days for BAT only). Post-treatment deaths were reported following completion study treatment (Week 80 for patients receiving BAT, or Week 260 for patients receiving ruxolitinib) or from the time of premature discontinuation. Patients were followed for survival every three months up to end of study. (NCT02038036)
Timeframe: Up to Week 260
| Intervention | Participants (Number) | ||
|---|---|---|---|
| Death occurring up to 30 days after end of randomised treatment. | Death occurring among patients who died after cross over to ruxolitinib (BAT arm only). | Death occurring more than 30 days after end of treatment. | |
| Best Available Therapy (BAT) | 1 | 3 | 2 |
| Ruxolitinib | 1 | 0 | 2 |
The ECOG scale of performance status described the level of functioning of participants in terms of their ability to care for themselves, daily activity, and physical ability. The ECOG performance was recorded as per ECOG performance status grades ranging from 0 (fully active, able to carry on all pre-disease performance without restriction) to 5 (dead). (NCT02038036)
Timeframe: Baseline and Week 28
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 0 at baseline71918606 | Grade 0 at baseline71918605 | Grade 1 at baseline71918605 | Grade 1 at baseline71918606 | |||||||||||||||||||||
| 0: Fully active, able to carry on all pre-disease | 1: Restricted in physically strenuous activity and | 2: Ambulatory and capable of all self-care but una | 3: Capable of only limited self-care, confined to | 4: Completely disabled. Cannot carry on any self-c | Missing | |||||||||||||||||||
| Ruxolitinib | 49 | |||||||||||||||||||||||
| Best Available Therapy (BAT) | 17 | |||||||||||||||||||||||
| Ruxolitinib | 2 | |||||||||||||||||||||||
| Best Available Therapy (BAT) | 38 | |||||||||||||||||||||||
| Ruxolitinib | 9 | |||||||||||||||||||||||
| Best Available Therapy (BAT) | 1 | |||||||||||||||||||||||
| Ruxolitinib | 10 | |||||||||||||||||||||||
| Best Available Therapy (BAT) | 5 | |||||||||||||||||||||||
| Ruxolitinib | 1 | |||||||||||||||||||||||
| Ruxolitinib | 0 | |||||||||||||||||||||||
| Best Available Therapy (BAT) | 0 | |||||||||||||||||||||||
| Best Available Therapy (BAT) | 13 | |||||||||||||||||||||||
Proportion of patients achieving a Hct control at Week 104 as defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 104 and with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8 Endpoint for Week 156, Week 208 and Week 260 were defined, similarly. (NCT02038036)
Timeframe: From Week 8 to Week 104, 156, 208 and 260
| Intervention | Participants (Count of Participants) | |||||||
|---|---|---|---|---|---|---|---|---|
| Week 10471918605 | Week 15671918605 | Week 20871918605 | Week 26071918605 | |||||
| HU Resistant | HU Intolerant | |||||||
| Ruxolitinib | 25 | |||||||
| Ruxolitinib | 9 | |||||||
| Ruxolitinib | 21 | |||||||
| Ruxolitinib | 7 | |||||||
| Ruxolitinib | 18 | |||||||
| Ruxolitinib | 4 | |||||||
| Ruxolitinib | 12 | |||||||
The Patient Global Impression of Change (PGIC) is comprised of a single question intended to measure a patient's perspective of improvement or deterioration over time relative to treatment. The PGIC uses a seven-point scale where one (1) equals very much improved and seven (7) equals very much worse. (NCT02038036)
Timeframe: Week 4, 8, 16, 28, 40, 52 and 80
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 471918605 | Week 471918606 | Week 871918605 | Week 871918606 | Week 1671918605 | Week 1671918606 | Week 2871918605 | Week 2871918606 | Week 4071918605 | Week 4071918606 | Week 5271918606 | Week 5271918605 | Week 6671918606 | Week 6671918605 | Week 8071918605 | Week 8071918606 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Very much improved | No change | Minimally worse | Much worse | Very much worse | Much improved | Minimally improved | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 21 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 14 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 50 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 11 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 14 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 15 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 35 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 18 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 13 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 13 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 12 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 33 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 19 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 25 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 12 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 15 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 23 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 30 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 27 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 28 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 31 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 22 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 24 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ruxolitinib | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The Patient Global Impression of Change (PGIC) is comprised of a single question intended to measure a patient's perspective of improvement or deterioration over time relative to treatment. The PGIC uses a seven-point scale where one (1) equals very much improved and seven (7) equals very much worse. (NCT02038036)
Timeframe: Baseline (last assessment before cross over), Week 4, 8, 16, 24, 28, 40, and 52 after cross-over
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week +471918608 | Week +871918608 | Week +1671918608 | Week +2471918608 | Week +2871918608 | Week +4071918608 | Week +5271918608 | ||||||||||||||||||||||||||||||||||||
| Minimally improved | Very much improved | Much improved | No change | Minimally worse | Much worse | |||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 10 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 13 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 11 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 25 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 9 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 7 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 1 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 12 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 28 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 6 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 19 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 5 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 8 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 18 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 15 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 17 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 16 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 3 | |||||||||||||||||||||||||||||||||||||||||
| Best Available Therapy (BAT) | 0 | |||||||||||||||||||||||||||||||||||||||||
Durable Primary Response was defined as any participant who achieved the primary outcome measure and who maintained their response up to 48 weeks after randomization. (NCT01243944)
Timeframe: 48 Weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Ruxolitinib | 20.0 |
| Best Available Therapy | 0.9 |
Primary response was defined as having achieved hematocrit control (the absence of phlebotomy eligibility beginning at the Week 8 visit and continuing through Week 32) and Spleen Volume Reduction (a greater than or equal to 35% reduction from baseline in spleen volume at Week 32). (NCT01243944)
Timeframe: 32 Weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Ruxolitinib | 22.7 |
| Best Available Therapy | 0.9 |
Complete Hematological Remission at Week 32 was defined as any participant who achieved hematocrit control with a platelet count less than or equal to 400 X 10^9/L and a white blood cell count less than or equal to 10 X 10^9/L. (NCT01243944)
Timeframe: 32 Weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Ruxolitinib | 23.6 |
| Best Available Therapy | 8.0 |
Durable Complete Hematological Remission was defined as any participant who achieved Complete Hematological Remission at Week 32 and maintained their response up to 48 weeks after randomization. (NCT01243944)
Timeframe: 48 Weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Ruxolitinib | 20.9 |
| Best Available Therapy | 0.9 |
Durable Hematocrit Control was defined as any participant who achieved phlebotomy eligibility independence from Week 8 to Week 32 and maintained hematocrit control up to 48 weeks after randomization. (NCT01243944)
Timeframe: 48 Weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Ruxolitinib | 54.5 |
| Best Available Therapy | 1.8 |
Durable Spleen Volume Reduction was defined as a participant who achieved at least 35% reduction from baseline in spleen volume at Week 32 and maintained that response 48 weeks after randomization. (NCT01243944)
Timeframe: 48 Weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Ruxolitinib | 37.3 |
| Best Available Therapy | 0.9 |
Duration of spleen volume reduction is defined as the time from the first occurrence of a >=35% reduction from baseline in spleen volume until the date of the first documented progression. (NCT01243944)
Timeframe: 256 Weeks
| Intervention | probability (Number) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 16 weeks | 32 weeks | 48 weeks | 64 weeks | 80 weeks | 96 weeks | 112 weeks | 128 weeks | 144 weeks | 160 weeks | 176 weeks | 192 weeks | 208 weeks | 224 weeks | 240 weeks | 256 weeks | |
| Ruxolitinib | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 0.98 | 0.95 | 0.95 | 0.95 | 0.93 | 0.93 | 0.93 | 0.87 | 0.72 | NA | NA |
Duration of the absence of phlebotomy eligibility is defined as the time from the first occurrence of absence of phlebotomy eligibility until the date of the first documented progression. (NCT01243944)
Timeframe: 256 Weeks
| Intervention | probability (Number) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 16 weeks | 32 weeks | 48 weeks | 64 weeks | 80 weeks | 96 weeks | 112 weeks | 128 weeks | 144 weeks | 160 weeks | 176 weeks | 192 weeks | 208 weeks | 224 weeks | 240 weeks | 256 weeks | |
| Ruxolitinib | 1.00 | 1.00 | 0.97 | 0.92 | 0.91 | 0.91 | 0.87 | 0.84 | 0.84 | 0.82 | 0.79 | 0.77 | 0.73 | 0.73 | 0.73 | 0.73 |
Duration of the overall clinicohematologic response was defined as the time from the first occurrence of complete response (CR) or partial response (PR) until the date of the first documented disease progression. (NCT01243944)
Timeframe: 256 Weeks
| Intervention | probability (Number) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 16 weeks | 32 weeks | 48 weeks | 64 weeks | 80 weeks | 96 weeks | 112 weeks | 128 weeks | 144 weeks | 160 weeks | 176 weeks | 192 weeks | 208 weeks | 224 weeks | 240 weeks | 256 weeks | |
| Ruxolitinib | 1.00 | 0.99 | 0.96 | 0.91 | 0.88 | 0.88 | 0.85 | 0.82 | 0.82 | 0.80 | 0.75 | 0.70 | 0.67 | 0.67 | 0.67 | 0.67 |
"Duration of the complete hematological remission is defined as the time from the first occurrence of complete hematological remission until the date of the first documented progression (end of response).~Kaplan-Meier estimates are provided for duration of complete hematological remission." (NCT01243944)
Timeframe: Through study completion, analysis was conducted when all participants had completed the Week 80 visit or discontinued the study
| Intervention | probability (Number) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 16 weeks | 32 weeks | 48 weeks | 64 weeks | 80 weeks | 96 weeks | 112 weeks | 128 weeks | 144 weeks | 160 weeks | 176 weeks | 192 weeks | 208 weeks | 224 weeks | 240 weeks | 256 weeks | |
| Ruxolitinib | 1.00 | 1.00 | 0.88 | 0.83 | 0.74 | 0.74 | 0.69 | 0.69 | 0.65 | 0.65 | 0.55 | 0.55 | 0.55 | 0.55 | NA | NA |
"Duration of the primary response is defined as the time from the first occurrence when both components of the primary endpoint are met until the date of the first documented disease progression (end of response).~Kaplan-Meier estimates are provided for duration of primary response." (NCT01243944)
Timeframe: Through study completion, analysis was conducted when all participants had completed the Week 80 visit or discontinued the study
| Intervention | probability (Number) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 16 weeks | 32 weeks | 48 weeks | 64 weeks | 80 weeks | 96 weeks | 112 weeks | 128 weeks | 144 weeks | 160 weeks | 176 weeks | 192 weeks | 208 weeks | 224 weeks | 240 weeks | 256 weeks | |
| Ruxolitinib | 1.00 | 1.00 | 0.92 | 0.92 | 0.92 | 0.88 | 0.84 | 0.84 | 0.84 | 0.79 | 0.79 | 0.74 | 0.74 | 0.74 | NA | NA |
Durable Complete or Partial Clinicohematologic Response was defined as any participant who achieved complete or partial clinicohematologic response per the European LeukemiaNet modified criteria for response in polycythemia vera at Week 32 and maintained that response 48 weeks after randomization. (NCT01243944)
Timeframe: 48 Weeks
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Complete response rate | Partial response rate | |
| Best Available Therapy | 0.9 | 0.9 |
| Ruxolitinib | 7.3 | 50.9 |
Overall Clinicohematologic Response is defined as any participant who achieved a complete or partial clinicohematologic response per the European LeukemiaNet modified criteria for response in polycythemia vera (PV). A Complete Response (CR) is defined as: hematocrit control, spleen volume reduction at least 35% from baseline, platelet count less than or equal to 400 x 10(9)/L, and white blood cell count less than or equal to 10 x 10(9)/L. A Partial Response (PR) is defined as hematocrit control or response in all 3 of the other criteria. (NCT01243944)
Timeframe: 32 Weeks
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Complete response rate | Partial response rate | |
| Best Available Therapy | 0.9 | 18.8 |
| Ruxolitinib | 8.2 | 54.5 |
71 reviews available for hydroxyurea and Erythremia
| Article | Year |
|---|---|
Appropriate management of polycythaemia vera with cytoreductive drug therapy: European LeukemiaNet 2021 recommendations.
Topics: Cytoreduction Surgical Procedures; Humans; Hydroxyurea; Polycythemia Vera; Quality of Life; Splenome | 2022 |
Recent advances in the treatment of polycythemia vera.
Topics: Humans; Hydroxyurea; Janus Kinase 2; Polycythemia Vera | 2022 |
Treatment options and pregnancy management for patients with PV and ET.
Topics: Aspirin; Female; Humans; Hydroxyurea; Janus Kinase 2; Janus Kinase Inhibitors; Myeloproliferative Di | 2022 |
SOHO State of the Art Updates and Next Questions | Polycythemia Vera: Is It Time to Rethink Treatment?
Topics: Aspirin; Humans; Hydroxyurea; Janus Kinase 2; Middle Aged; Polycythemia Vera; Primary Myelofibrosis; | 2023 |
Treatment of hydroxyurea-resistant/intolerant polycythemia vera: a discussion of best practices.
Topics: Hematocrit; Humans; Hydroxyurea; Janus Kinase 2; Nitriles; Polycythemia Vera | 2023 |
BCR::ABL1 negative myeloproliferative neoplasms: A review focused on essential thrombocythemia and polycythemia vera.
Topics: Aspirin; Humans; Hydroxyurea; Mutation; Polycythemia Vera; Thrombocythemia, Essential | 2023 |
Ropeginterferon alfa-2b for the treatment of patients with polycythemia vera.
Topics: Humans; Hydroxyurea; Interferon alpha-2; Interferon-alpha; Polycythemia Vera; Polyethylene Glycols; | 2020 |
Novel agents for the treatment of polycythemia vera: an insight into preclinical research and early phase clinical trials.
Topics: Animals; Disease Progression; Drug Development; Histone Deacetylase Inhibitors; Humans; Hydroxyurea; | 2020 |
Givinostat: an emerging treatment for polycythemia vera.
Topics: Animals; Carbamates; Disease Progression; Histone Deacetylase Inhibitors; Humans; Hydroxyurea; Janus | 2020 |
Novel and combination therapies for polycythemia vera and essential thrombocythemia: the dawn of a new era.
Topics: Bone Marrow; Clinical Trials as Topic; Combined Modality Therapy; DNA Methylation; Drugs, Investigat | 2020 |
Polycythemia Vera: Rapid Evidence Review.
Topics: Antineoplastic Agents; Fibrinolytic Agents; Genetic Markers; Humans; Hydroxyurea; Janus Kinase 2; Mu | 2021 |
Polycythemia vera: from new, modified diagnostic criteria to new therapeutic approaches.
Topics: Age Factors; Calreticulin; Female; Hematocrit; Humans; Hydroxyurea; Interferons; Janus Kinase 2; Mal | 2017 |
Novel therapeutic approaches in polycythemia vera.
Topics: Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Half-Life; Humans; Hydroxyu | 2018 |
Do All Patients With Polycythemia Vera or Essential Thrombocythemia Need Cytoreduction?
Topics: Antineoplastic Agents; Bone Marrow; Cell Proliferation; Evidence-Based Medicine; Hematopoiesis; Huma | 2018 |
Clinical outcomes under hydroxyurea treatment in polycythemia vera: a systematic review and meta-analysis.
Topics: Hemorrhage; Humans; Hydroxyurea; Polycythemia Vera; Primary Myelofibrosis; Prognosis; Risk Factors; | 2019 |
Nonmelanoma skin cancer associated with Hydroxyurea treatment: Overview of the literature and our own experience.
Topics: Carcinoma, Squamous Cell; Cohort Studies; Female; Humans; Hydroxyurea; Male; Photochemotherapy; Poly | 2019 |
Polycythemia vera: current pharmacotherapy and future directions.
Topics: Alkylating Agents; Aspirin; Hematocrit; Hematologic Agents; Hematopoiesis; Humans; Hydroxyurea; Inte | 2013 |
Emerging drugs for polycythemia vera.
Topics: Humans; Hydroxyurea; Interferon-alpha; Janus Kinase 2; Polycythemia Vera; Protein Kinase Inhibitors | 2013 |
Therapeutic options for patients with polycythemia vera and essential thrombocythemia refractory/resistant to hydroxyurea.
Topics: Antineoplastic Agents; Busulfan; Disease Management; Drug Resistance; Histone Deacetylase Inhibitors | 2014 |
Leukemic transformation in myeloproliferative neoplasms: therapy-related or unrelated?
Topics: Antineoplastic Agents; Cell Transformation, Neoplastic; Disease Progression; Humans; Hydroxyurea; Ja | 2014 |
Polycythemia vera disease burden: contributing factors, impact on quality of life, and emerging treatment options.
Topics: Clinical Trials, Phase III as Topic; Combined Modality Therapy; Cost of Illness; Disease Progression | 2014 |
[Treatment strategy for myeloproliferative neoplasms].
Topics: Adrenal Cortex Hormones; Aspirin; Calreticulin; Carbamates; Clinical Trials as Topic; Drug Therapy, | 2014 |
Polycythemia vera and essential thrombocythemia: 2015 update on diagnosis, risk-stratification and management.
Topics: Aspirin; Calreticulin; Diagnosis, Differential; Disease Management; Humans; Hydroxyurea; Janus Kinas | 2015 |
Historical views, conventional approaches, and evolving management strategies for myeloproliferative neoplasms.
Topics: Antineoplastic Agents; Calreticulin; Hematopoietic Stem Cell Transplantation; Humans; Hydroxyurea; J | 2015 |
Anagrelide hydrochloride and ruxolitinib for treatment of polycythemia vera.
Topics: Aspirin; Drug Therapy, Combination; Fibrinolytic Agents; Humans; Hydroxyurea; Interferon-alpha; Nitr | 2015 |
New Therapeutic Approaches in Polycythemia Vera.
Topics: Antineoplastic Agents; Female; Humans; Hydroxyurea; Interferon-alpha; Male; Polycythemia Vera | 2015 |
Pharmacobiological Approach for the Clinical Development of Ruxolitinib in Myeloproliferative Neoplasms.
Topics: Bone Marrow; Combined Modality Therapy; Disease Progression; Female; Fibrosis; Humans; Hydroxyurea; | 2015 |
Polycythemia Vera: An Appraisal of the Biology and Management 10 Years After the Discovery of JAK2 V617F.
Topics: Aspirin; Clinical Trials, Phase II as Topic; Disease Progression; Female; Humans; Hydroxyurea; Incid | 2015 |
Management of polycythaemia vera: a critical review of current data.
Topics: Disease Management; Drug Resistance; Humans; Hydroxyurea; Janus Kinase 2; Nitriles; Polycythemia Ver | 2016 |
How We Identify and Manage Patients with Inadequately Controlled Polycythemia Vera.
Topics: Antineoplastic Agents; Aspirin; Humans; Hydroxyurea; Interferon-alpha; Janus Kinase 2; Nitriles; Pol | 2016 |
Where to Turn for Second-Line Cytoreduction After Hydroxyurea in Polycythemia Vera?
Topics: Busulfan; Cell Proliferation; Humans; Hydroxyurea; Janus Kinase 2; Leukemia, Myeloid, Acute; Nitrile | 2016 |
Second line therapies in polycythemia vera: What is the optimal strategy after hydroxyurea failure?
Topics: Clinical Trials as Topic; Humans; Hydroxyurea; Janus Kinases; Polycythemia Vera; Protein Kinase Inhi | 2016 |
Polycythemia Vera Management and Challenges in the Community Health Setting.
Topics: Community Health Centers; Drug Resistance, Neoplasm; Elective Surgical Procedures; Female; Hematocri | 2017 |
Evidence and expertise in the management of polycythemia vera and essential thrombocythemia.
Topics: Aspirin; Humans; Hydroxyurea; Interferon-alpha; Janus Kinase 2; Mutation; Phlebotomy; Polycythemia V | 2008 |
A unified definition of clinical resistance and intolerance to hydroxycarbamide in polycythaemia vera and primary myelofibrosis: results of a European LeukemiaNet (ELN) consensus process.
Topics: Antineoplastic Agents; Consensus Development Conferences as Topic; Drug Resistance; Humans; Hydroxyu | 2010 |
Pathogenesis and management of essential thrombocythemia.
Topics: Acute Disease; Aged; Aspirin; Clone Cells; Disease Management; Disease Progression; Humans; Hydroxyu | 2009 |
Hydroxyurea: The drug of choice for polycythemia vera and essential thrombocythemia.
Topics: Aged; Agranulocytosis; Alkylating Agents; Clinical Trials as Topic; Combined Modality Therapy; Disea | 2006 |
Do we know more about essential thrombocythemia because of JAK2V617F?
Topics: Female; Humans; Hydroxyurea; Janus Kinase 2; Polycythemia Vera; Pregnancy; Pregnancy Complications; | 2009 |
Polycythemia vera and essential thrombocythemia: 2012 update on diagnosis, risk stratification, and management.
Topics: Acute Disease; Age Factors; Alkylating Agents; Anticoagulants; Aspirin; Busulfan; Disease Management | 2012 |
Molecular basis of erythrocyte adhesion to endothelial cells in diseases.
Topics: Anemia, Sickle Cell; Animals; Cell Adhesion; Cell Adhesion Molecules; Diabetes Mellitus; Erythrocyte | 2013 |
[True polycythemia: current views of pathogenesis, diagnostics and treatment].
Topics: Age Factors; Algorithms; Antineoplastic Agents; Aspirin; Benzamides; Combined Modality Therapy; Hema | 2012 |
[Diagnosis and therapy of polycythemia vera in the era of JAK2].
Topics: Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Diagnosis, Differential; DNA Mutational Analysis; | 2013 |
[Polycythemia vera].
Topics: Aged; Diagnosis, Differential; Erythrocyte Count; Female; Hematocrit; Humans; Hydroxyurea; Male; Mid | 2002 |
Modern treatment strategies in polycythemia vera.
Topics: Age Factors; Antineoplastic Agents; Drug Therapy, Combination; Humans; Hydroxyurea; Interferon-alpha | 2003 |
Polycythemia vera.
Topics: Antineoplastic Agents; Diagnosis, Differential; Hematocrit; Humans; Hydroxyurea; Interferons; Phlebo | 2003 |
Management of the myeloproliferative disorders : distinguishing data from dogma.
Topics: Abnormalities, Drug-Induced; Adult; Aged; Anticoagulants; Contraindications; Female; Humans; Hydroxy | 2004 |
The leukemia controversy in myeloproliferative disorders: is it a natural progression of disease, a secondary sequela of therapy, or a combination of both?
Topics: Age Factors; Aged; Antineoplastic Agents, Alkylating; Antiviral Agents; Disease Progression; Female; | 2004 |
Oral squamous cell carcinoma during long-term treatment with hydroxyurea.
Topics: Aged; Carcinoma, Squamous Cell; Drug Administration Schedule; Humans; Hydroxyurea; Male; Nucleic Aci | 2004 |
Thrombosis and haemorrhage in polycythaemia vera and essential thrombocythaemia.
Topics: Aged; Aspirin; Hemorrhage; Humans; Hydroxyurea; Middle Aged; Polycythemia Vera; Risk Factors; Thromb | 2005 |
Evidence-based management of polycythemia vera.
Topics: Evidence-Based Medicine; Humans; Hydroxyurea; Interferon-alpha; Middle Aged; Platelet Aggregation In | 2006 |
Leg ulcers in elderly on hydroxyurea: a single center experience in Ph- myeloproliferative disorders and review of literature.
Topics: Age Factors; Aged; Aged, 80 and over; Female; Humans; Hydroxyurea; Leg Ulcer; Male; Myeloproliferati | 2006 |
Long-term incidence of hematological evolution in three French prospective studies of hydroxyurea and pipobroman in polycythemia vera and essential thrombocythemia.
Topics: Antineoplastic Agents, Alkylating; Drug Therapy, Combination; Female; Humans; Hydroxyurea; Interfero | 2006 |
Treatment of polycythemia vera.
Topics: Antineoplastic Agents; Aspirin; Female; Humans; Hydroxyurea; Interferons; Janus Kinase 2; Leukemia; | 2006 |
A review of the therapeutic agents used in the management of polycythaemia vera.
Topics: Hematocrit; Humans; Hydroxyurea; Interferons; Pipobroman; Polycythemia Vera; Randomized Controlled T | 2007 |
The management of elderly patients with myeloproliferative disorders.
Topics: Adult; Age Factors; Aged; Bone Marrow Transplantation; Busulfan; Chronic Disease; Humans; Hydroxyure | 1993 |
Risk of leukaemia, carcinoma, and myelofibrosis in 32P- or chemotherapy-treated patients with polycythaemia vera: a prospective analysis of 682 cases. The "French Cooperative Group for the Study of Polycythaemias".
Topics: Actuarial Analysis; Acute Disease; Carcinoma; Cause of Death; Disease Progression; Follow-Up Studies | 1996 |
From efficacy to safety: a Polycythemia Vera Study group report on hydroxyurea in patients with polycythemia vera.
Topics: Adult; Aged; Antineoplastic Agents; Female; Follow-Up Studies; Humans; Hydroxyurea; Male; Middle Age | 1997 |
[Efficacious treatment of a fatal blood disease: polycythemia vera].
Topics: Acute Disease; Alkylating Agents; Busulfan; Chlorambucil; Humans; Hydroxyurea; Leukemia, Myeloid; Le | 1997 |
Hydroxyurea-induced leg ulceration in 14 patients.
Topics: Adult; Antineoplastic Agents; Female; Humans; Hydroxyurea; Leg Ulcer; Male; Middle Aged; Myeloprolif | 1998 |
[Vaquez disease. Diagnosis, course, treatment].
Topics: Aged; Antineoplastic Agents, Alkylating; Antisickling Agents; Diagnosis, Differential; Female; Human | 1998 |
Transition of polycythemia vera to chronic neutrophilic leukemia.
Topics: Busulfan; Humans; Hydroxyurea; Leukemia, Neutrophilic, Chronic; Male; Middle Aged; Polycythemia Vera | 1999 |
Treatment of polycythaemia vera and essential thrombocythaemia.
Topics: Adult; Aged; Aspirin; Chlorambucil; Disease Progression; Female; Hemorrhage; Humans; Hydroxyurea; In | 1998 |
Diagnosis and treatment of polycythemia vera and possible future study designs of the PVSG.
Topics: Blood Platelets; Forecasting; Humans; Hydroxyurea; Interferon-alpha; Megakaryocytes; Platelet Aggreg | 2000 |
Treatment of the myeloproliferative disorders with 32P.
Topics: Adult; Aged; Alkylating Agents; Chlorambucil; Clinical Trials as Topic; Combined Modality Therapy; D | 2000 |
A clinical update in polycythemia vera and essential thrombocythemia.
Topics: Age Factors; Carcinogens; Cell Transformation, Neoplastic; Chronic Disease; Enzyme Inhibitors; Femal | 2000 |
[Polycythemia vera: current status of therapy].
Topics: Adult; Aged; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Bloodletting; Clinical Trials | 2000 |
[What vascular events suggest a myeloproliferative disorder?].
Topics: Adult; Aged; Alkylating Agents; Arterial Occlusive Diseases; Cross-Sectional Studies; Erythromelalgi | 2000 |
Diagnosis and treatment of thrombocythemia in myeloproliferative disorders.
Topics: Enzyme Inhibitors; Humans; Hydroxyurea; Immunologic Factors; Interferon-alpha; Polycythemia Vera; Qu | 2001 |
Therapeutic options for essential thrombocythemia and polycythemia vera.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Antineoplastic Agents; Aspirin; Busulfan; Fibrinolytic Agen | 2002 |
[Essential thrombocythemia: conventional therapy].
Topics: Adult; Antineoplastic Agents; Busulfan; Follow-Up Studies; Hemorrhage; Humans; Hydroxyurea; Immunolo | 1991 |
Polycythemia: evaluation and management.
Topics: Adult; Aged; Bloodletting; Humans; Hydroxyurea; Middle Aged; Polycythemia; Polycythemia Vera | 1989 |
43 trials available for hydroxyurea and Erythremia
| Article | Year |
|---|---|
The MDM2 antagonist idasanutlin in patients with polycythemia vera: results from a single-arm phase 2 study.
Topics: Humans; Hydroxyurea; Nausea; para-Aminobenzoates; Polycythemia Vera; Proto-Oncogene Proteins c-mdm2; | 2022 |
Symptom burden and quality of life in patients with high-risk essential thrombocythaemia and polycythaemia vera receiving hydroxyurea or pegylated interferon alfa-2a: a post-hoc analysis of the MPN-RC 111 and 112 trials.
Topics: Female; Humans; Hydroxyurea; Interferon-alpha; Male; Polycythemia Vera; Polyethylene Glycols; Qualit | 2022 |
A randomized phase 3 trial of interferon-α vs hydroxyurea in polycythemia vera and essential thrombocythemia.
Topics: Disease Progression; Humans; Hydroxyurea; Interferon-alpha; Polycythemia Vera; Thrombocythemia, Esse | 2022 |
A randomized phase 3 trial of interferon-α vs hydroxyurea in polycythemia vera and essential thrombocythemia.
Topics: Disease Progression; Humans; Hydroxyurea; Interferon-alpha; Polycythemia Vera; Thrombocythemia, Esse | 2022 |
A randomized phase 3 trial of interferon-α vs hydroxyurea in polycythemia vera and essential thrombocythemia.
Topics: Disease Progression; Humans; Hydroxyurea; Interferon-alpha; Polycythemia Vera; Thrombocythemia, Esse | 2022 |
A randomized phase 3 trial of interferon-α vs hydroxyurea in polycythemia vera and essential thrombocythemia.
Topics: Disease Progression; Humans; Hydroxyurea; Interferon-alpha; Polycythemia Vera; Thrombocythemia, Esse | 2022 |
Ruxolitinib versus best available therapy in inadequately controlled polycythaemia vera without splenomegaly (RESPONSE-2): 5-year follow up of a randomised, phase 3b study.
Topics: Adolescent; Adult; Antineoplastic Combined Chemotherapy Protocols; Follow-Up Studies; Humans; Hydrox | 2022 |
Efficacy and safety of ruxolitinib in patients with newly-diagnosed polycythemia vera: futility analysis of the RuxoBEAT clinical trial of the GSG-MPN study group.
Topics: Humans; Hydroxyurea; Janus Kinases; Medical Futility; Nitriles; Polycythemia Vera; Pyrimidines | 2023 |
A phase II trial to assess the efficacy and safety of ropeginterferon α-2b in Chinese patients with polycythemia vera.
Topics: China; Clinical Trials, Phase II as Topic; East Asian People; Humans; Hydroxyurea; Interferon alpha- | 2023 |
Pegylated interferon alfa-2a for polycythemia vera or essential thrombocythemia resistant or intolerant to hydroxyurea.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Drug Resistance, Neoplasm; Female; Humans; Hy | 2019 |
Long-term efficacy and safety of ruxolitinib versus best available therapy in polycythaemia vera (RESPONSE): 5-year follow up of a phase 3 study.
Topics: Antineoplastic Combined Chemotherapy Protocols; Antiviral Agents; Drug Therapy, Combination; Fibrino | 2020 |
Treatment Patterns and Blood Counts in Patients With Polycythemia Vera Treated With Hydroxyurea in the United States: An Analysis From the REVEAL Study.
Topics: Adult; Aged; Aged, 80 and over; Blood Cell Count; Female; Humans; Hydroxyurea; Longitudinal Studies; | 2020 |
Data-driven analysis of the kinetics of the JAK2V617F allele burden and blood cell counts during hydroxyurea treatment of patients with polycythemia vera, essential thrombocythemia, and primary myelofibrosis.
Topics: Aged; Alleles; Antineoplastic Agents; Blood Cell Count; Cohort Studies; Female; Humans; Hydroxyurea; | 2021 |
Ruxolitinib is effective and safe in Japanese patients with hydroxyurea-resistant or hydroxyurea-intolerant polycythemia vera with splenomegaly.
Topics: Adult; Aged; Aged, 80 and over; Asian People; Female; Hematocrit; Humans; Hydroxyurea; Janus Kinase | 2018 |
Efficacy and safety of ruxolitinib after and versus interferon use in the RESPONSE studies.
Topics: Adult; Aged; Antineoplastic Agents; Bloodletting; Combined Modality Therapy; Cross-Over Studies; Dru | 2018 |
Efficacy and safety of ruxolitinib after and versus interferon use in the RESPONSE studies.
Topics: Adult; Aged; Antineoplastic Agents; Bloodletting; Combined Modality Therapy; Cross-Over Studies; Dru | 2018 |
Efficacy and safety of ruxolitinib after and versus interferon use in the RESPONSE studies.
Topics: Adult; Aged; Antineoplastic Agents; Bloodletting; Combined Modality Therapy; Cross-Over Studies; Dru | 2018 |
Efficacy and safety of ruxolitinib after and versus interferon use in the RESPONSE studies.
Topics: Adult; Aged; Antineoplastic Agents; Bloodletting; Combined Modality Therapy; Cross-Over Studies; Dru | 2018 |
Comprehensive haematological control with ruxolitinib in patients with polycythaemia vera resistant to or intolerant of hydroxycarbamide.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Drug Resistance, Neoplasm; Humans; Hydroxyure | 2018 |
Cepeginterferon alfa-2b in the treatment of chronic myeloproliferative diseases.
Topics: Adult; Gene Frequency; Humans; Hydroxyurea; Interferon alpha-2; Interferon-alpha; Janus Kinase 2; Mi | 2018 |
Thromboembolic events in polycythemia vera.
Topics: Age Factors; Anticoagulants; Aspirin; Humans; Hydroxyurea; Interferons; Nitriles; Phlebotomy; Polycy | 2019 |
Safety and efficacy findings from the open-label, multicenter, phase 3b, expanded treatment protocol study of ruxolitinib for treatment of patients with polycythemia vera who are resistant/intolerant to hydroxyurea and for whom no alternative treatments a
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Drug Resistance, Neoplasm; Female; Follow-Up | 2019 |
A phase II study of Givinostat in combination with hydroxycarbamide in patients with polycythaemia vera unresponsive to hydroxycarbamide monotherapy.
Topics: Adult; Aged; Aged, 80 and over; Carbamates; Dose-Response Relationship, Drug; Drug Administration Sc | 2013 |
A phase 2 study of ruxolitinib, an oral JAK1 and JAK2 Inhibitor, in patients with advanced polycythemia vera who are refractory or intolerant to hydroxyurea.
Topics: Adult; Aged; Aged, 80 and over; Anemia; Contraindications; Drug-Related Side Effects and Adverse Rea | 2014 |
Busulfan in patients with polycythemia vera or essential thrombocythemia refractory or intolerant to hydroxyurea.
Topics: Aged; Aged, 80 and over; Alkylating Agents; Blood Cell Count; Busulfan; Comorbidity; Disease Progres | 2014 |
Interferon α-2b gains high sustained response therapy for advanced essential thrombocythemia and polycythemia vera with JAK2V617F positive mutation.
Topics: Adult; Aged; Female; Humans; Hydroxyurea; Interferon alpha-2; Interferon-alpha; Janus Kinase 2; Kapl | 2014 |
Ruxolitinib versus standard therapy for the treatment of polycythemia vera.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Blood Cell Count; Female; Humans; Hydroxyurea | 2015 |
The efficacy and safety of continued hydroxycarbamide therapy versus switching to ruxolitinib in patients with polycythaemia vera: a randomized, double-blind, double-dummy, symptom study (RELIEF).
Topics: Adult; Aged; Aged, 80 and over; Cross-Over Studies; Double-Blind Method; Drug Substitution; Fatigue; | 2017 |
Hydroxyurea (HU) is effective in reducing JAK2V617F mutated clone size in the peripheral blood of essential thrombocythemia (ET) and polycythemia vera (PV) patients.
Topics: Bone Marrow; Clone Cells; Hematopoietic Stem Cells; Humans; Hydroxyurea; Janus Kinase 2; Mutation, M | 2009 |
Modulation of JAK2 V617F allele burden dynamics by hydroxycarbamide in polycythaemia vera and essential thrombocythaemia patients.
Topics: Adult; Aged; Aged, 80 and over; Alleles; Female; Follow-Up Studies; Genetic Load; Humans; Hydroxyure | 2011 |
Treatment of polycythemia vera with hydroxyurea and pipobroman: final results of a randomized trial initiated in 1980.
Topics: Adult; Aged; Aged, 80 and over; Cohort Studies; Female; Follow-Up Studies; Humans; Hydroxyurea; Male | 2011 |
Cardiovascular events and intensity of treatment in polycythemia vera.
Topics: Aged; Antineoplastic Agents; Cardiovascular Diseases; Combined Modality Therapy; Female; Follow-Up S | 2013 |
Cardiovascular events and intensity of treatment in polycythemia vera.
Topics: Aged; Antineoplastic Agents; Cardiovascular Diseases; Combined Modality Therapy; Female; Follow-Up S | 2013 |
Cardiovascular events and intensity of treatment in polycythemia vera.
Topics: Aged; Antineoplastic Agents; Cardiovascular Diseases; Combined Modality Therapy; Female; Follow-Up S | 2013 |
Cardiovascular events and intensity of treatment in polycythemia vera.
Topics: Aged; Antineoplastic Agents; Cardiovascular Diseases; Combined Modality Therapy; Female; Follow-Up S | 2013 |
Hematologic aspects of liver transplantation for Budd-Chiari syndrome with special reference to myeloproliferative disorders.
Topics: Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Anticoagulants; Aspirin; Blood Coagulati | 2002 |
Bone marrow pathology in essential thrombocythemia: interobserver reliability and utility for identifying disease subtypes.
Topics: Adult; Antineoplastic Agents; Aspirin; Biopsy; Blood Cell Count; Drug Therapy, Combination; Hematolo | 2008 |
Circulating hematopoietic progenitor cells in polycythemia vera: the in vivo effect of hydroxyurea.
Topics: Aged; Cell Count; Colony-Forming Units Assay; Follow-Up Studies; Hematopoietic Stem Cells; Humans; H | 1995 |
Acute leukaemia after hydroxyurea therapy in polycythaemia vera and allied disorders: prospective study of efficacy and leukaemogenicity with therapeutic implications.
Topics: Acute Disease; Adult; Aged; Bone Marrow; Humans; Hydroxyurea; Leukemia; Middle Aged; Myeloproliferat | 1994 |
Indications, procedure and results for the treatment of polycythaemia vera by bleeding, pipobroman and hydroxyurea.
Topics: Acute Disease; Bloodletting; Combined Modality Therapy; Humans; Hydroxyurea; Leukemia; Phosphorus Ra | 1993 |
Risk of leukaemia, carcinoma, and myelofibrosis in 32P- or chemotherapy-treated patients with polycythaemia vera: a prospective analysis of 682 cases. The "French Cooperative Group for the Study of Polycythaemias".
Topics: Actuarial Analysis; Acute Disease; Carcinoma; Cause of Death; Disease Progression; Follow-Up Studies | 1996 |
Treatment of polycythemia vera: use of 32P alone or in combination with maintenance therapy using hydroxyurea in 461 patients greater than 65 years of age. The French Polycythemia Study Group.
Topics: Actuarial Analysis; Aged; Alkylating Agents; Combined Modality Therapy; Disease Progression; Follow- | 1997 |
Treatment of polycythemia vera: the use of hydroxyurea and pipobroman in 292 patients under the age of 65 years.
Topics: Antineoplastic Agents; Female; Follow-Up Studies; Humans; Hydroxyurea; Male; Middle Aged; Pipobroman | 1997 |
Hydroxyurea treatment reduces haematopoietic progenitor growth and CD34 positive cells in polycythaemia vera and essential thrombocythaemia.
Topics: Adult; Aged; Aged, 80 and over; Antigens, CD34; Cell Division; Cells, Cultured; Colony-Forming Units | 2000 |
[Treatment of polycythemia. I--Using radiophosphorus with or without treatment in 483 patients over 65 years of age].
Topics: Aged; Aged, 80 and over; Combined Modality Therapy; Female; Humans; Hydroxyurea; Leukemia; Male; Pho | 1998 |
[Treatment of polycythemia. II.--Comparison of hydroxyurea with pipobroman in 294 patients less than 65 years of age].
Topics: Adult; Antineoplastic Agents; Female; Follow-Up Studies; Humans; Hydroxyurea; Male; Middle Aged; Pip | 1998 |
Leukemogenic risk of hydroxyurea therapy as a single agent in polycythemia vera and essential thrombocythemia: N- and K-ras mutations and microsatellite instability in chromosomes 5 and 7 in 69 patients.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Cell Transformation, Neoplastic; Chromosomes, Human, Pai | 2002 |
Maintenance therapy of 32P-induced remission in polycythemia vera. A clinical trial of chlorambucil and hydroxy-urea in 109 cases.
Topics: Chlorambucil; Drug Tolerance; Humans; Hydroxyurea; Long-Term Care; Phosphorus Radioisotopes; Polycyt | 1978 |
[Treatment of polycythemia vera with hydroxyurea or pipobroman. Efficacy and toxicity analysed from a protocol of 96 patients under 65 years of age. Le Groupe d'Etude des Polyglobulies].
Topics: Digestive System Diseases; Female; Follow-Up Studies; Humans; Hydroxyurea; Male; Middle Aged; Pipobr | 1992 |
Intermediary analysis of a French protocol of treatment of polycythemias (1980-1990): 253 patients. The French Group for the Study of Polycythemias.
Topics: Clinical Protocols; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Hydroxyurea; Male; | 1991 |
The choice of treatment in polycythaemia vera.
Topics: Bloodletting; Chlorambucil; Clinical Trials as Topic; Humans; Hydroxyurea; Phosphorus Radioisotopes; | 1986 |
Therapeutic recommendations in polycythemia vera based on Polycythemia Vera Study Group protocols.
Topics: Acute Disease; Age Factors; Bloodletting; Chlorambucil; Combined Modality Therapy; False Positive Re | 1986 |
259 other studies available for hydroxyurea and Erythremia
| Article | Year |
|---|---|
Ruxolitinib-treated polycythemia vera patients and their risk of secondary malignancies.
Topics: Adult; Aged; Aged, 80 and over; Female; Follow-Up Studies; Humans; Hydroxyurea; Incidence; Janus Kin | 2021 |
Cytoreductive treatment in real life: a chart review analysis on 1440 patients with polycythemia vera.
Topics: Aged; Aspirin; Cytoreduction Surgical Procedures; Humans; Hydroxyurea; Phlebotomy; Polycythemia Vera | 2022 |
Aggressive cutaneous squamous cell carcinoma in a hydroxyurea- and ruxolitinib-pretreated patient with polycythaemia vera.
Topics: Aged, 80 and over; Carcinoma, Squamous Cell; Humans; Hydroxyurea; Male; Nitriles; Polycythemia Vera; | 2022 |
Conventional interferon-α 2b versus hydroxyurea for newly-diagnosed patients with polycythemia vera in a real world setting: a retrospective study based on 286 patients from a single center.
Topics: Humans; Hydroxyurea; Interferon-alpha; Polycythemia Vera; Retrospective Studies | 2022 |
Essential thrombocythemia and aortic dissection,causal or incidental association?
Topics: Aortic Dissection; Humans; Hydroxyurea; Janus Kinase 2; Male; Middle Aged; Polycythemia Vera; Thromb | 2022 |
Real-world analysis of main clinical outcomes in patients with polycythemia vera treated with ruxolitinib or best available therapy after developing resistance/intolerance to hydroxyurea.
Topics: Hemorrhage; Humans; Hydroxyurea; Leukemia, Myeloid, Acute; Neoplasms, Second Primary; Nitriles; Poly | 2022 |
Hemorrhages in Polycythemia Vera and Essential Thrombocythemia: Epidemiology, Description, and Risk Factors-Learnings from a Large Cohort.
Topics: Aspirin; Hemorrhage; Humans; Hydroxyurea; Male; Polycythemia Vera; Risk Factors; Thrombocythemia, Es | 2022 |
Ruxolitinib in patients with polycythemia vera with hydroxyurea resistance or intolerance.
Topics: Humans; Hydroxyurea; Nitriles; Polycythemia Vera; Pyrazoles; Pyrimidines | 2022 |
Cases in the management of polycythemia vera: switching from hydroxyurea to ruxolitinib to resolve symptoms and improve quality of life.
Topics: Humans; Hydroxyurea; Nitriles; Polycythemia Vera; Pyrazoles; Pyrimidines; Quality of Life | 2022 |
Prevalence and clinical outcomes of polycythemia vera and essential thrombocythemia with hydroxyurea resistance or intolerance.
Topics: Humans; Hydroxyurea; Janus Kinase 2; Middle Aged; Polycythemia Vera; Prevalence; Retrospective Studi | 2022 |
Second malignancies among older patients with classical myeloproliferative neoplasms treated with hydroxyurea.
Topics: Aged; Aged, 80 and over; Humans; Hydroxyurea; Leukemia, Myeloid, Acute; Medicare; Myelodysplastic Sy | 2023 |
Prediction of thrombosis in post-polycythemia vera and post-essential thrombocythemia myelofibrosis: a study on 1258 patients.
Topics: Humans; Hydroxyurea; Janus Kinase Inhibitors; Polycythemia Vera; Primary Myelofibrosis; Thrombocythe | 2022 |
Topics: Adult; Aged; Anemia; Bone Marrow; Female; Hemoglobins; Humans; Hydroxyurea; Male; Middle Aged; Myelo | 2022 |
A novel integrated biomarker index for the assessment of hematological responses in MPNs during treatment with hydroxyurea and interferon-alpha2.
Topics: Biomarkers; Humans; Hydroxyurea; Interferon-alpha; Myeloproliferative Disorders; Polycythemia Vera | 2023 |
The gut microbiota in patients with polycythemia vera is distinct from that of healthy controls and varies by treatment.
Topics: Gastrointestinal Microbiome; Humans; Hydroxyurea; Inflammation; Interferon-alpha; Polycythemia Vera | 2023 |
Management of polycythemia vera: A survey of treatment patterns in Italy.
Topics: Humans; Hydroxyurea; Italy; Janus Kinase 2; Janus Kinase Inhibitors; Polycythemia Vera; Pyrazoles | 2023 |
Bilateral adrenal and pulmonary haemorrhages as an initial presentation of polycythaemia vera.
Topics: Bone Marrow; Hemorrhage; Humans; Hydrocortisone; Hydroxyurea; Hyperplasia; Male; Polycythemia Vera | 2022 |
Differences between aquagenic and non-aquagenic pruritus in myeloproliferative neoplasms: An observational study of 500 patients.
Topics: Humans; Hydroxyurea; Myeloproliferative Disorders; Polycythemia Vera; Primary Myelofibrosis; Pruritu | 2023 |
Polycythemia vera: aspects of its current diagnosis and initial treatment.
Topics: Bone Marrow; Humans; Hydroxyurea; Interferon-alpha; Janus Kinase 2; Myeloproliferative Disorders; Po | 2023 |
[A case of recurrent non embolic stroke with non-fluent aphasia due to polycythemia vera].
Topics: Aged; Aphasia; Cerebral Infarction; Female; Humans; Hydroxyurea; Polycythemia Vera; Stroke | 2023 |
Cost-effectiveness of ropeginterferon alfa-2b-njft for the treatment of polycythemia vera.
Topics: Adult; Cost-Benefit Analysis; Humans; Hydroxyurea; Interferon alpha-2; Interferon-alpha; Polycythemi | 2023 |
Detection of primary myelofibrosis in blood serum via Raman spectroscopy assisted by machine learning approaches; correlation with clinical diagnosis.
Topics: Biomarkers; Humans; Hydroxyurea; Polycythemia Vera; Primary Myelofibrosis; Serum; Spectrum Analysis, | 2023 |
Moving toward disease modification in polycythemia vera.
Topics: Humans; Hydroxyurea; Interferon-alpha; Janus Kinase 2; Leukemia, Myeloid, Acute; Polycythemia Vera; | 2023 |
[Interferon therapy for polycythemia vera].
Topics: Humans; Hydroxyurea; Immunotherapy; Myeloproliferative Disorders; Polycythemia Vera | 2023 |
Reducing the burden of MPN.
Topics: Humans; Hydroxyurea; Interferon-alpha; Polycythemia Vera; Polyethylene Glycols; Recombinant Proteins | 2019 |
Polycythaemia vera, ruxolitinib, and hydroxyurea: where do we go now?
Topics: Female; Humans; Hydroxyurea; Male; Nitriles; Polycythemia Vera; Pyrazoles; Pyrimidines | 2020 |
Patterns of Hydroxyurea Prescription and Use in Routine Clinical Management of Polycythemia Vera: A Multicenter Chart Review Study
Topics: Antineoplastic Agents; Female; Humans; Hydroxyurea; Male; Middle Aged; Polycythemia Vera; Retrospect | 2020 |
Genomic characterization of patients with polycythemia vera developing resistance to hydroxyurea.
Topics: Antineoplastic Agents; Biomarkers, Tumor; Drug Resistance, Neoplasm; Gene Expression Regulation, Neo | 2021 |
Ropeginterferon alfa-2 b for the therapy of polycythemia vera.
Topics: Czech Republic; Humans; Hydroxyurea; Interferon-alpha; Myeloproliferative Disorders; Polycythemia Ve | 2020 |
[Recent advances in polycythemia vera treatment].
Topics: Aspirin; Clinical Trials as Topic; Humans; Hydroxyurea; Interferon-alpha; Janus Kinase 2; Polycythem | 2020 |
[Development of skin squamous cell carcinoma on the scalp in a hydroxycarbamide-treated polycythemia vera patient].
Topics: Aged; Carcinoma, Squamous Cell; Humans; Hydroxyurea; Polycythemia Vera; Scalp; Thrombocythemia, Esse | 2020 |
Reduced CXCL4/PF4 expression as a driver of increased human hematopoietic stem and progenitor cell proliferation in polycythemia vera.
Topics: Antineoplastic Agents; Cell Proliferation; Down-Regulation; Hematopoietic Stem Cells; Humans; Hydrox | 2021 |
Differential expression of hydroxyurea transporters in normal and polycythemia vera hematopoietic stem and progenitor cell subpopulations.
Topics: Antineoplastic Agents; Cell Proliferation; Cells, Cultured; Gene Expression Regulation, Neoplastic; | 2021 |
ABCG2 Is Overexpressed on Red Blood Cells in Ph-Negative Myeloproliferative Neoplasms and Potentiates Ruxolitinib-Induced Apoptosis.
Topics: Apoptosis; ATP Binding Cassette Transporter, Subfamily G, Member 2; Binding Sites; Cell Differentiat | 2021 |
Management of hydroxyurea resistant or intolerant polycythemia vera.
Topics: Humans; Hydroxyurea; Leukemia, Myeloid, Acute; Phlebotomy; Polycythemia Vera; Thrombosis | 2021 |
Hydroxyurea-induced genital ulcers and erosions: Two case reports.
Topics: Aged, 80 and over; Humans; Hydroxyurea; Leg Ulcer; Male; Myeloproliferative Disorders; Polycythemia | 2021 |
Evaluation of the need for cytoreduction and its potential carcinogenicity in children and young adults with myeloproliferative neoplasms.
Topics: Adolescent; Adult; Antineoplastic Agents; Aspirin; Child; Female; Fibrinolytic Agents; Follow-Up Stu | 2021 |
Real-World Dosing Patterns of Ruxolitinib in Patients With Polycythemia Vera Who Are Resistant to or Intolerant of Hydroxyurea.
Topics: Aged; Drug Resistance, Neoplasm; Female; Humans; Hydroxyurea; Male; Middle Aged; Nitriles; Polycythe | 2021 |
Occult hepatitis B infection reactivation after ruxolitinib therapy.
Topics: Aged; Antiviral Agents; Drug Resistance; Enzyme Inhibitors; Guanine; Hepatitis B, Chronic; Humans; H | 2017 |
57-Year-Old Woman With Abdominal Pain.
Topics: Abdominal Pain; Antineoplastic Agents; Bone Marrow; Budd-Chiari Syndrome; Diagnosis, Differential; F | 2017 |
A reappraisal of the benefit-risk profile of hydroxyurea in polycythemia vera: A propensity-matched study.
Topics: Antineoplastic Agents; Biomarkers; Combined Modality Therapy; Comorbidity; Female; Follow-Up Studies | 2017 |
Pulmonary Hypertension Associated with Pulmonary Veno-occlusive Disease in Patients with Polycythemia Vera.
Topics: Aged; Humans; Hydroxyurea; Hypertension, Pulmonary; Japan; Male; Nitriles; Polycythemia Vera; Pulmon | 2017 |
An updated review of the JAK1/2 inhibitor (ruxolitinib) in the Philadelphia-negative myeloproliferative neoplasms.
Topics: Aged; Animals; Blood Cell Count; Clinical Trials, Phase III as Topic; Disease Models, Animal; Diseas | 2018 |
Epstein-Barr virus-positive mucocutaneous ulcer in a patient with polycythemia vera treated with oral hydroxyurea.
Topics: Administration, Oral; Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; E | 2018 |
New guidelines from the NCCN for polycythemia vera.
Topics: Antineoplastic Agents; Cytoreduction Surgical Procedures; Disease Management; Humans; Hydroxyurea; N | 2017 |
Health Care Costs and Thromboembolic Events in Hydroxyurea-Treated Patients with Polycythemia Vera.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Cross-Sectional Studies; Drug Resistance, Neoplasm; | 2018 |
Incidence of solid tumors in polycythemia vera treated with phlebotomy with or without hydroxyurea: ECLAP follow-up data.
Topics: Aged; Aged, 80 and over; Female; Follow-Up Studies; Humans; Hydroxyurea; Incidence; Male; Middle Age | 2018 |
A patient case highlighting the myriad of cutaneous adverse effects of prolonged use of hydroxyurea.
Topics: Aged; Biopsy; Carcinoma, Squamous Cell; Dermatomyositis; Humans; Hydroxyurea; Keratosis; Male; Polyc | 2017 |
Successful therapy for pyoderma gangrenosum with a Janus kinase 2 inhibitor.
Topics: Biopsy; Exons; Female; Humans; Hydroxyurea; Janus Kinase 2; Middle Aged; Mutation; Nitriles; Phlebot | 2018 |
Pegylated interferon Alfa-2a and hydroxyurea in polycythemia vera and essential thrombocythemia: differential cellular and molecular responses.
Topics: Antineoplastic Agents; Antiviral Agents; Humans; Hydroxyurea; Interferon-alpha; Janus Kinase 2; Muta | 2018 |
Impact of hydroxycarbamide and interferon-α on red cell adhesion and membrane protein expression in polycythemia vera.
Topics: Alleles; Biomarkers; Cell Adhesion; Cell Adhesion Molecules; Erythrocyte Membrane; Erythrocytes; Fem | 2018 |
Sudden hemichorea and frontal lobe syndrome: a rare presentation of unbalanced polycythaemia vera.
Topics: Aged, 80 and over; Brain; Chorea; Cognitive Dysfunction; Frontal Lobe; Humans; Hydroxyurea; Male; Po | 2018 |
Response to "Questions arising on phlebotomy in polycythemia vera: prophylactic measures to reduce thromboembolic events require patient-focused decisions" by Heidel et al.
Topics: Humans; Hydroxyurea; Phlebotomy; Polycythemia Vera | 2018 |
A Flushed Face and Dilated Retinal Veins.
Topics: Aged; Follow-Up Studies; Humans; Hydroxyurea; Hyperemia; Male; Phlebotomy; Polycythemia Vera; Retina | 2018 |
Polycythemia vera and essential thrombocythemia: 2019 update on diagnosis, risk-stratification and management.
Topics: Adult; Aspirin; Bone Marrow; Busulfan; Disease Management; Disease Progression; Hemorrhage; Humans; | 2019 |
Hydroxyurea-induced dermatomyositis koebnerizing at the site of previous shingles.
Topics: Adult; Dermatomyositis; Herpes Zoster; Humans; Hydroxyurea; Male; Polycythemia Vera; Skin | 2019 |
Different effect of hydroxyurea and phlebotomy on prevention of arterial and venous thrombosis in Polycythemia Vera.
Topics: Humans; Hydroxyurea; Incidence; Phlebotomy; Polycythemia Vera; Thrombosis; Treatment Outcome; Venous | 2018 |
A case report of cerebral infarction caused by polycythemia vera.
Topics: Cerebral Infarction; Female; Humans; Hydroxyurea; Interferons; Middle Aged; Polycythemia Vera | 2018 |
Polycythemia vera and hydroxyurea resistance/intolerance: a monocentric retrospective analysis.
Topics: Adult; Aged; Aged, 80 and over; Drug Resistance; Female; Fever; Follow-Up Studies; Humans; Hydroxyur | 2019 |
Treatment of Philadelphia-negative myeloproliferative neoplasms in accelerated/blastic phase with azacytidine. Clinical results and identification of prognostic factors.
Topics: Aged; Antimetabolites, Antineoplastic; Azacitidine; Blast Crisis; Female; Humans; Hydroxyurea; Leuke | 2019 |
Cerebral Hemorrhage of a 50-Year-Old Female Patient with Polycythemia Vera.
Topics: Biopsy; Blood Component Removal; Bone Marrow Examination; Cerebral Angiography; Cerebral Hemorrhage; | 2019 |
Second cancer in Philadelphia negative myeloproliferative neoplasms (MPN-K). A nested case-control study.
Topics: Antineoplastic Agents; Case-Control Studies; Humans; Hydroxyurea; Neoplasms, Second Primary; Nitrile | 2019 |
Telomere shortening in Ph-negative chronic myeloproliferative neoplasms: a biological marker of polycythemia vera and myelofibrosis, regardless of hydroxycarbamide therapy.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Biomarkers; Child; Child, Preschool; Clone Cells; Female | 2013 |
Treatment target in polycythemia vera.
Topics: Antineoplastic Agents; Cardiovascular Diseases; Female; Hematocrit; Humans; Hydroxyurea; Male; Phleb | 2013 |
Treatment target in polycythemia vera.
Topics: Antineoplastic Agents; Cardiovascular Diseases; Female; Hematocrit; Humans; Hydroxyurea; Male; Phleb | 2013 |
Treatment target in polycythemia vera.
Topics: Antineoplastic Agents; Cardiovascular Diseases; Female; Hematocrit; Humans; Hydroxyurea; Male; Phleb | 2013 |
Treatment target in polycythemia vera.
Topics: Antineoplastic Agents; Cardiovascular Diseases; Female; Hematocrit; Humans; Hydroxyurea; Male; Phleb | 2013 |
Genetic predisposition to molecular response in patients with myeloproliferative neoplasms treated with hydroxycarbamide.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Arginase; Female; Gene Frequency; Genetic Pre | 2013 |
Treatment target in polycythemia vera.
Topics: Antineoplastic Agents; Cardiovascular Diseases; Female; Hematocrit; Humans; Hydroxyurea; Male; Phleb | 2013 |
Cutaneous involvement by post-polycythemia vera myelofibrosis.
Topics: Aged; Aspirin; Biopsy; Cell Lineage; Disease Progression; Drug Therapy, Combination; Fibrosis; Hemat | 2014 |
Postcoital generalised pruritus as a first symptom of polycythaemia vera.
Topics: Antineoplastic Agents; Blood Cell Count; Chronic Inducible Urticaria; Hematocrit; Humans; Hydroxyure | 2013 |
Successful long-term treatment of Philadelphia chromosome-negative myeloproliferative neoplasms with combination of hydroxyurea and anagrelide.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Female; Humans; Hydr | 2013 |
Complex karyotype in a polycythemia vera patient with a novel SETD1B/GTF2H3 fusion gene.
Topics: Chromosome Deletion; Chromosomes, Human, Pair 15; Chromosomes, Human, Pair 6; Combined Modality Ther | 2014 |
Perspectives on the impact of JAK-inhibitor therapy upon inflammation-mediated comorbidities in myelofibrosis and related neoplasms.
Topics: Chronic Disease; Comorbidity; Humans; Hydroxyurea; Inflammation; Interferon alpha-2; Interferon-alph | 2014 |
Hydroxyurea-associated acral erythema in a patient with polycythemia vera.
Topics: Dose-Response Relationship, Drug; Hand-Foot Syndrome; Humans; Hydroxyurea; Male; Middle Aged; Polycy | 2014 |
Interferon apha 2b for treating patients with JAK2V617F positive polycythemia vera and essential thrombocytosis.
Topics: Adult; Aged; Female; Humans; Hydroxyurea; Interferon alpha-2; Interferon-alpha; Janus Kinase 2; Male | 2014 |
The thrombotic events in polycythemia vera patients may be related to increased oxidative stress.
Topics: Adult; Aged; Aged, 80 and over; Antioxidants; Aspirin; Body Mass Index; Bone Marrow; Case-Control St | 2014 |
Bullet 'manicure': does lead prevent hydroxyurea-induced cutaneous toxicity?
Topics: Accidents; Antineoplastic Agents; Humans; Hydroxyurea; Lead; Male; Middle Aged; Polycythemia Vera; S | 2014 |
An exceptional case of renal artery restenosis in a patient with polycythaemia vera.
Topics: Angioplasty, Balloon; Antineoplastic Agents; Drug Administration Schedule; Female; Hematocrit; Human | 2014 |
Expansion of circulating CD56bright natural killer cells in patients with JAK2-positive chronic myeloproliferative neoplasms during treatment with interferon-α.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Case-Control Studies; CD56 Antigen; Female; G | 2015 |
Essential differences in clinical and bone marrow features in BCR/ABL-positive thrombocythemia compared to thrombocythemia in the BCR/ABL-negative myeloproliferative neoplasms essential thrombocythemia and polycythemia vera.
Topics: Aged; Alleles; Benzamides; Biopsy; Bone Marrow; Diagnosis, Differential; Drug Therapy, Combination; | 2015 |
The role of parathyroidectomy in JAK2 mutation negative polycythemia vera.
Topics: Aged, 80 and over; Erythrocyte Indices; Female; Humans; Hydroxyurea; Janus Kinase 2; Parathyroid Neo | 2014 |
Nuclear hypersegmentation of neutrophils, eosinophils, and basophils due to hydroxycarbamide (hydroxyurea).
Topics: Aged; Basophils; Cell Nucleus; Eosinophils; Humans; Hydroxyurea; Male; Neutrophils; Nucleic Acid Syn | 2014 |
Consequences of the JAK2V617F allele burden for the prediction of transformation into myelofibrosis from polycythemia vera and essential thrombocythemia.
Topics: Alleles; Bone Marrow; Disease Progression; Humans; Hydroxyurea; Janus Kinase 2; Mutation; Polycythem | 2015 |
Hydroxyurea-induced stomatocytes in a patient presenting with polycythemia vera.
Topics: Aged, 80 and over; Antisickling Agents; Erythrocytes, Abnormal; Humans; Hydroxyurea; Male; Polycythe | 2015 |
Patterns of presentation and thrombosis outcome in patients with polycythemia vera strictly defined by WHO-criteria and stratified by calendar period of diagnosis.
Topics: Adolescent; Adult; Age Factors; Aged; Aged, 80 and over; Anticoagulants; Aspirin; Austria; Female; H | 2015 |
Prediction of thrombotic and hemorrhagic events during polycythemia vera or essential thrombocythemia based on leukocyte burden.
Topics: Adult; Aged; Aged, 80 and over; Area Under Curve; Blood Cell Count; Comorbidity; Databases, Factual; | 2015 |
Masked polycythaemia vera: presenting features, response to treatment and clinical outcomes.
Topics: Adult; Aged; Aged, 80 and over; Alleles; Amino Acid Substitution; Disease-Free Survival; Female; Hum | 2016 |
New and treatment-relevant risk stratification for thrombosis in essential thrombocythemia and polycythemia vera.
Topics: Age Factors; Aged; Aspirin; Drug Administration Schedule; Enzyme Inhibitors; Fibrinolytic Agents; Hu | 2015 |
[Polycythemia vera: the disadvantages of overproduction].
Topics: Aged; Aspirin; Bloodletting; Diagnosis, Differential; Female; Hematocrit; Humans; Hydroxyurea; Inter | 2015 |
Comparative long-term effects of interferon α and hydroxyurea on human hematopoietic progenitor cells.
Topics: Aged; Animals; Cell Differentiation; Cell Proliferation; Female; Hematopoietic Stem Cells; Humans; H | 2015 |
Diagnosis and Treatment of Primary Erythrocytosis in a Dog: A Case Report.
Topics: Animals; Antineoplastic Agents; Diagnosis, Differential; Dog Diseases; Dogs; Euthanasia, Animal; Fat | 2015 |
Evolving Therapeutic Options for Polycythemia Vera: Perspectives of the Canadian Myeloproliferative Neoplasms Group.
Topics: Aged; Antimetabolites; Canada; Drug Therapy, Combination; Humans; Hydroxyurea; Middle Aged; Polycyth | 2015 |
Symptomatic Profiles of Patients With Polycythemia Vera: Implications of Inadequately Controlled Disease.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Fatigue; Female; Fever; Humans; Hydroxyurea; | 2016 |
Frequency and prognostic value of resistance/intolerance to hydroxycarbamide in 890 patients with polycythaemia vera.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Drug Resistance; Drug Tolerance; Female; Humans; Hydroxy | 2016 |
Current opinion and consensus statement regarding the diagnosis, prognosis, and treatment of patients with essential thrombocythemia: a survey of the Spanish Group of Ph-negative Myeloproliferative Neoplasms (GEMFIN) using the Delphi method.
Topics: Bone Marrow Examination; Delphi Technique; Diagnosis, Differential; Disease Management; DNA Mutation | 2016 |
Multicenter Retrospective Analysis of Turkish Patients with Chronic Myeloproliferative Neoplasms.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Asian People; Chronic Disease; Fe | 2017 |
Hydroxyurea for Treatment of Nephrotic Syndrome Associated With Polycythemia Vera.
Topics: Humans; Hydroxyurea; Male; Middle Aged; Nephrotic Syndrome; Polycythemia Vera | 2016 |
Incidence, Survival and Prevalence Statistics of Classical Myeloproliferative Neoplasm in Korea.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Child; Child, Preschool; Databases, Factual; Drug Prescr | 2016 |
Risk of thrombosis according to need of phlebotomies in patients with polycythemia vera treated with hydroxyurea.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Cell Count; Combined Modality Therapy; Drug Resist | 2017 |
Alox5 Blockade Eradicates JAK2V617F-Induced Polycythemia Vera in Mice.
Topics: Animals; Arachidonate 5-Lipoxygenase; Blotting, Western; Disease Models, Animal; Enzyme-Linked Immun | 2017 |
[Dermatologic complications of long-term hydroxyurea therapy].
Topics: Antineoplastic Agents; Carcinoma, Squamous Cell; Humans; Hydroxyurea; Keratosis, Actinic; Male; Midd | 2017 |
Polycythemia vera and essential thrombocythemia: 2017 update on diagnosis, risk-stratification, and management.
Topics: Aspirin; Calreticulin; Diagnosis, Differential; Erythropoietin; Humans; Hydroxyurea; Interferon-alph | 2017 |
Can pegylated interferon improve the outcome of polycythemia vera patients?
Topics: Adolescent; Adult; Aged; Disease Progression; Female; Humans; Hydroxyurea; Interferon-alpha; Janus K | 2017 |
Longitudinal melanonychia on multiple nails induced by hydroxyurea.
Topics: Aged; Antineoplastic Agents; Female; Humans; Hydroxyurea; Nail Diseases; Pigmentation Disorders; Pol | 2017 |
Diagnosis and Management of Polycythemia Vera in a Ferret (
Topics: Animals; Antineoplastic Agents; Diarrhea; Erythropoietin; Fatal Outcome; Female; Ferrets; Hydroxyure | 2016 |
Rapid decline of JAK2V617F levels during hydroxyurea treatment in patients with polycythemia vera and essential thrombocythemia.
Topics: Aged; Aged, 80 and over; Amino Acid Substitution; Antisickling Agents; Female; Humans; Hydroxyurea; | 2008 |
Frequent reduction or absence of detection of the JAK2-mutated clone in JAK2V617F-positive patients within the first years of hydroxyurea therapy.
Topics: Aged; Aged, 80 and over; Amino Acid Substitution; Antisickling Agents; Cohort Studies; DNA Primers; | 2008 |
Thrombotic complications of polycythemia vera.
Topics: Adult; Aged; Aged, 80 and over; Case-Control Studies; Erythrocyte Count; Female; Hemoglobins; Humans | 2008 |
Hydroxyurea and anagrelide combination therapy in patients with chronic myeloproliferative diseases resistant or intolerant to monotherapy.
Topics: Adult; Aged; Aged, 80 and over; Drug Resistance; Drug Therapy, Combination; Female; Humans; Hydroxyu | 2008 |
Correlation between leukocytosis and thrombosis in Philadelphia-negative chronic myeloproliferative neoplasms.
Topics: Aged; Female; Humans; Hydroxyurea; Janus Kinase 2; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Neg | 2009 |
B-mode ultrasound and contrast-enhanced ultrasound pattern of focal extramedullary hematopoiesis of the spleen in a patient with myeloproliferative disease.
Topics: Aged; Biopsy, Needle; Bloodletting; Bone Marrow; Contrast Media; Diagnosis, Differential; Follow-Up | 2009 |
Peripheral retinal neovascularization associated with polycythemia rubra vera.
Topics: Aged; Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Bevacizuma | 2009 |
A fertile XY/XX chimeric male with chronic myeloid leukemia in a minor 46,XX cell line and a history of polycythemia vera and trisomy 9 in the major 46,XY cell line.
Topics: Aged; Antineoplastic Agents; Benzamides; Bone Marrow; Chimera; Chromosomes, Human, Pair 9; Chromosom | 2009 |
[Cutaneous side effects of hydroxyurea treatment for polycythemia vera].
Topics: Aged; Antisickling Agents; Carcinoma, Squamous Cell; Drug Eruptions; Female; Humans; Hydroxyurea; Le | 2009 |
Dermatomyositis-like eruption induced by hydroxyurea: a case report.
Topics: Aged; Dermatomyositis; Drug Eruptions; Hand Dermatoses; Humans; Hydroxyurea; Male; Nucleic Acid Synt | 2009 |
Perimalleolar ulcers in hydroxyurea treated patients with concomitant chronic venous disease: diagnostic pitfalls.
Topics: Aged; Antineoplastic Agents; Chronic Disease; Humans; Hydroxyurea; Hyperpigmentation; Leukemia, Myel | 2005 |
Hydroxyurea induced oscillations in twelve patients with polycythemia vera.
Topics: Biological Clocks; Female; Humans; Hydroxyurea; Leukocyte Count; Male; Platelet Count; Polycythemia | 2010 |
Hydroxyurea does not appreciably reduce JAK2 V617F allele burden in patients with polycythemia vera or essential thrombocythemia.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Alleles; Amino Acid Substitution; Female; Gene Frequency | 2010 |
[Leg ulcers in patient affected by polycythemia vera in treatment with hydroxycarbamide. Case report].
Topics: Aged; Female; Humans; Hydroxyurea; Leg Ulcer; Polycythemia Vera; Treatment Outcome | 2010 |
Nitric oxide derivatives and soluble plasma selectins in patients with myeloproliferative neoplasms.
Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; DNA Mutational Analysis; E-Selectin; Endothelium, Va | 2010 |
A case of hydroxyurea-induced longitudinal melanonychia.
Topics: Aged; Antineoplastic Agents; Diagnosis, Differential; Female; Humans; Hydroxyurea; Melanosis; Nail D | 2010 |
Treatment outcome in a cohort of young patients with polycythemia vera.
Topics: Adult; Antineoplastic Agents; Aspirin; Cohort Studies; Combined Modality Therapy; Disease Progressio | 2010 |
Histopathological manifestations of membranoproliferative glomerulonephritis and glomerular expression of plasmalemmal vesicle-associated protein-1 in a patient with polycythemia vera.
Topics: Aged; Anticoagulants; Antihypertensive Agents; Biopsy; Carrier Proteins; Drug Therapy, Combination; | 2010 |
Treatment related changes in antifibrinolytic activity in patients with polycythemia vera.
Topics: Adult; Aged; alpha-2-Antiplasmin; Biomarkers; Carboxypeptidase B2; Case-Control Studies; Female; Fib | 2010 |
Hyperkalaemia associated with hydroxyurea in a patient with polycythaemia vera.
Topics: Aged, 80 and over; Female; Humans; Hydroxyurea; Hyperkalemia; Polycythemia Vera | 2011 |
Coexistence of β-thalassemia and polycythemia vera.
Topics: Aged; beta-Thalassemia; Female; Hematologic Tests; Humans; Hydroxyurea; Janus Kinase 2; Mutation; Po | 2011 |
Pruritic indurated plaques on the legs of a 62-year-old woman--quiz case. Polycythemia vera (PCV).
Topics: Aspirin; Biopsy; Female; Humans; Hydroxyurea; Janus Kinase 2; Leg; Middle Aged; Point Mutation; Poly | 2011 |
Differential expression of JAK2 and Src kinase genes in response to hydroxyurea treatment in polycythemia vera and essential thrombocythemia.
Topics: Adult; Aged; Aged, 80 and over; Case-Control Studies; Female; Gene Expression Profiling; Gene Expres | 2011 |
Recurrence of hydroxyurea-induced leg ulcer after discontinuation of treatment.
Topics: Aged, 80 and over; Biopsy; Humans; Hydroxyurea; Leg Ulcer; Male; Polycythemia Vera; Recurrence; Trea | 2011 |
Hydroxyurea dose impacts hematologic parameters in polycythemia vera and essential thrombocythemia but does not appreciably affect JAK2-V617F allele burden.
Topics: Alleles; Antineoplastic Agents; Dose-Response Relationship, Drug; Gene Frequency; Granulocytes; Hema | 2011 |
[Hydroxyurea induced-leg ulcer in polycythemia vera].
Topics: Aged; Antineoplastic Agents; Female; Humans; Hydroxyurea; Leg Ulcer; Polycythemia Vera | 2011 |
Clearance of circulating activated platelets in polycythemia vera and essential thrombocythemia.
Topics: Adult; Aged; Aged, 80 and over; Animals; Blood Platelets; Case-Control Studies; Female; Flow Cytomet | 2011 |
Increase in circulating CD4⁺CD25⁺Foxp3⁺ T cells in patients with Philadelphia-negative chronic myeloproliferative neoplasms during treatment with IFN-α.
Topics: Adult; Aged; Antineoplastic Agents; Female; Forkhead Transcription Factors; Humans; Hydroxyurea; Int | 2011 |
Antineutrophil cytoplasmic antibody-associated vasculitis in a patient with polycythemia vera after long-term hydroxyurea treatment.
Topics: Aged; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Antineoplastic Agents; Diagnosis, | 2011 |
JAK2V617F mutation and hydroxyurea treatment as determinants of immature platelet parameters in essential thrombocythemia and polycythemia vera patients.
Topics: Blood Platelets; Humans; Hydroxyurea; Janus Kinase 2; Mutation, Missense; Phenotype; Platelet Count; | 2011 |
Porokeratosis in patients with polycythemia rubra vera: a new side effect of hydroxyurea?
Topics: Aged; Humans; Hydroxyurea; Male; Polycythemia Vera; Porokeratosis | 2012 |
Anticoagulant-resistant thrombophilia in a patient with polycythemia vera: a case report.
Topics: Aged; Anticoagulants; Aspirin; Factor Xa; Factor Xa Inhibitors; Fatal Outcome; Heparin, Low-Molecula | 2011 |
Concurrent basal cell and squamous cell carcinomas associated with hydroxyurea therapy.
Topics: Aged; Antimetabolites; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Female; Humans; Hydroxyurea; | 2011 |
A multidisciplinary team approach to hydroxyurea-associated chronic wound with squamous cell carcinoma.
Topics: Antineoplastic Agents; Carcinoma, Squamous Cell; Chronic Disease; Debridement; Female; Humans; Hydro | 2012 |
How to manage polycythemia vera.
Topics: Adult; Combined Modality Therapy; Erythropoietin; Female; Humans; Hydroxyurea; Janus Kinase 2; Male; | 2012 |
Assessment and prognostic value of the European LeukemiaNet criteria for clinicohematologic response, resistance, and intolerance to hydroxyurea in polycythemia vera.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Cell Transformation, Neoplastic; Drug Resistance; Drug T | 2012 |
Coexistence of a myeloproliferative disorder and secondary polycythemia in the same patient.
Topics: Aged, 80 and over; Comorbidity; Drug Resistance; Erythropoiesis; Erythropoietin; Humans; Hydroxyurea | 2012 |
JAK2V617F allele burden is associated with transformation to myelofibrosis.
Topics: Adult; Aged; Aged, 80 and over; Alleles; Cell Transformation, Neoplastic; Female; Humans; Hydroxyure | 2012 |
[Polycythemia vera].
Topics: Aged; Algorithms; Alleles; Bone Marrow Examination; Diagnosis, Differential; Erythropoietin; Female; | 2012 |
How I treat polycythemia vera.
Topics: Female; Humans; Hydroxyurea; Interferon alpha-2; Interferon-alpha; Janus Kinase 2; Janus Kinases; Ma | 2012 |
Homoharringtonine is an effective therapy for patients with polycythemia vera or essential thrombocythemia who have failed or were intolerant to hydroxycarbamide or interferon-α therapy.
Topics: Adult; Aged; Cephalotaxus; Dose-Response Relationship, Drug; Female; Harringtonines; Homoharringtoni | 2013 |
Givinostat and hydroxyurea synergize in vitro to induce apoptosis of cells from JAK2(V617F) myeloproliferative neoplasm patients.
Topics: Amino Acid Substitution; Antineoplastic Agents; Apoptosis; Blotting, Western; Carbamates; Caspase 3; | 2013 |
Polycythemia vera, the hematocrit, and blood-volume physiology.
Topics: Antineoplastic Agents; Cardiovascular Diseases; Female; Hematocrit; Humans; Hydroxyurea; Male; Phleb | 2013 |
Differential effects of hydroxyurea and INC424 on mutant allele burden and myeloproliferative phenotype in a JAK2-V617F polycythemia vera mouse model.
Topics: Alleles; Amino Acid Substitution; Animals; Bone Marrow Transplantation; Disease Models, Animal; Fema | 2013 |
Increased CD11/CD18 expression and altered metabolic activity on polymorphonuclear leukocytes from patients with polycythemia vera and essential thrombocythemia.
Topics: Adult; Aged; CD18 Antigens; Cell Adhesion; Clone Cells; Escherichia coli; Female; Flow Cytometry; Ge | 2002 |
Tumor lysis syndrome induced by hydroxyurea therapy for leukemic transformation of polycythemia vera.
Topics: Aged; Cell Transformation, Neoplastic; Humans; Hydroxyurea; Leukemia; Male; Polycythemia Vera; Tumor | 2002 |
The optimal management of polycythaemia vera.
Topics: Disease Progression; Humans; Hydroxyurea; Nucleic Acid Synthesis Inhibitors; Platelet Count; Polycyt | 2003 |
Polycythemia vera responds to imatinib mesylate.
Topics: Adult; Benzamides; Blood Platelets; Enzyme Inhibitors; Female; Hematocrit; Humans; Hydroxyurea; Imat | 2003 |
Paraneoplastic eosinophilic fasciitis: a case report.
Topics: Anti-Inflammatory Agents; Antineoplastic Agents; Eosinophilia; Fasciitis; Female; Humans; Hydroxyure | 2003 |
[Hydroxyurea-induced pneumonitis].
Topics: Antineoplastic Agents; Diagnosis, Differential; Humans; Hydroxyurea; Male; Middle Aged; Pneumonia; P | 2003 |
Huge post-operative ulcer following hydroxyurea therapy in a patient with polycythemia vera.
Topics: Aged; Anti-Bacterial Agents; Busulfan; Combined Modality Therapy; Debridement; Female; Heparin; Hern | 2003 |
[Unilateral internal cerebral vein thrombosis in MRI].
Topics: Angiography, Digital Subtraction; Antisickling Agents; Cerebral Angiography; Cerebral Veins; Diagnos | 2004 |
Polycythemia vera and pregnancy: a case report with the use of hydroxyurea in the first trimester.
Topics: Adult; Antineoplastic Agents; Diagnosis, Differential; Female; Humans; Hydroxyurea; Infant, Newborn; | 2004 |
The effects of hydroxyurea on PRV-1 expression in patients with essential thrombocythemia and polycythemia vera.
Topics: Aged; Aged, 80 and over; Biomarkers; Computer Systems; Female; GPI-Linked Proteins; Humans; Hydroxyu | 2004 |
[Choice of therapy and overall survival in patients with chronic myeloproliferative diseases].
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Busulfan; | 2004 |
Eosinophilic leukemic transformation in polycythemia rubra vera (PRV).
Topics: Aged; Chromosome Aberrations; Cytogenetic Analysis; Humans; Hydroxyurea; Hypereosinophilic Syndrome; | 2005 |
Safety profile of hydroxyurea in the treatment of patients with Philadelphia-negative chronic myeloproliferative disorders.
Topics: Adult; Aged; Aged, 80 and over; Busulfan; Enzyme Inhibitors; Female; Humans; Hydroxyurea; Leukemia, | 2005 |
Gottron-like papules induced by hydroxyurea.
Topics: Aged; Drug Eruptions; Female; Hand Dermatoses; Humans; Hydroxyurea; Polycythemia Vera; Skin Diseases | 2005 |
Transition of polycythemia vera to chronic myeloid leukaemia.
Topics: Aged; Female; Humans; Hydroxyurea; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Polycythemia Ve | 2005 |
[Black discoloration of nails in polycythaemia vera].
Topics: Aged; Antineoplastic Agents; Biopsy, Needle; Diagnosis, Differential; Female; Humans; Hydroxyurea; N | 2005 |
Polycythemia vera with uncommon presentations.
Topics: Adult; Aged; Anemia, Hypochromic; beta-Thalassemia; Case Management; Disease Progression; Genotype; | 2003 |
[Focal segmental glomerulosclerosis in a patient with polycythemia vera].
Topics: Aged; Disease Progression; Female; Glomerulosclerosis, Focal Segmental; Humans; Hydroxyurea; Nitroso | 2005 |
Treatment of polycythemia vera with hydroxyurea.
Topics: Adult; Aged; Antisickling Agents; Female; Humans; Hydroxyurea; Male; Middle Aged; Polycythemia Vera; | 1989 |
Hydroxyurea induced perimalleolar ulcers.
Topics: Aged; Ankle; Antineoplastic Agents; Humans; Hydroxyurea; Leg Ulcer; Leukemia, Myelogenous, Chronic, | 2006 |
Usefulness of JAK2V617F mutation in distinguishing idiopathic erythrocytosis from polycythemia vera.
Topics: Adult; Aged; Aged, 80 and over; Amino Acid Substitution; Aspirin; Bone Marrow; Diagnosis, Differenti | 2007 |
An unusual case of toe ulceration.
Topics: Adult; Aspirin; Erythropoietin; Fibrinolytic Agents; Foot Ulcer; Hematocrit; Humans; Hydroxyurea; Ma | 2006 |
[The diagnosis and treatment of polycythemia rubra vera manifesting as acute cerebral stroke].
Topics: Adult; Aged; Arsenic Trioxide; Arsenicals; Combined Modality Therapy; Female; Harringtonines; Hemato | 2006 |
Long-term effects of the treatment of polycythemia vera with recombinant interferon-alpha.
Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Humans; Hydroxyurea; Immunotherapy; Interfero | 2006 |
Hydroxyurea therapy increases plasma erythropoietin in patients with essential thrombocythaemia or polycythaemia vera.
Topics: Aged; Aged, 80 and over; Blood Platelets; Erythropoietin; Female; Humans; Hydroxyurea; Male; Middle | 2006 |
Painful leg ulcers and a rash in a patient with polycythaemia rubra vera. Diagnosis: hydroxyurea-induced leg ulceration and dermatomyositis-like skin changes.
Topics: Antineoplastic Agents; Female; Humans; Hydroxyurea; Leg Ulcer; Middle Aged; Myeloproliferative Disor | 2006 |
Hydroxyurea associated leg ulcer succesfully treated with hyperbaric oxygen in a diabetic patient.
Topics: Diabetes Complications; Diabetes Mellitus, Type 2; Humans; Hydroxyurea; Hyperbaric Oxygenation; Leg | 2007 |
Unanswered questions in polycythaemia vera.
Topics: Age Factors; Humans; Hydroxyurea; Interferons; Janus Kinase 2; Mutation; Phlebotomy; Polycythemia Ve | 2007 |
Application of PRV-1 mRNA expression level and JAK2V617F mutation for the differentiating between polycytemia vera and secondary erythrocytosis and assessment of treatment by interferon or hydroxyurea.
Topics: Diagnosis, Differential; GPI-Linked Proteins; Humans; Hydroxyurea; Interferon-alpha; Isoantigens; Ja | 2007 |
Improvement of fibrosis in a patient with chronic myeloproliferative disease.
Topics: Adult; Biopsy; Follow-Up Studies; Humans; Hydroxyurea; Interferon-alpha; Male; Nucleic Acid Synthesi | 2007 |
Hydroxyurea-induced leg ulcers treated with a protease-modulating matrix.
Topics: Aged; Aged, 80 and over; Animals; Bandages, Hydrocolloid; Cattle; Cellulose, Oxidized; Collagen; Fem | 2007 |
The presence of JAK2V617F in primary myelofibrosis or its allele burden in polycythemia vera predicts chemosensitivity to hydroxyurea.
Topics: Adult; Age Factors; Aged; Alleles; Cohort Studies; DNA Mutational Analysis; Drug Resistance; Female; | 2008 |
Prevention of thrombosis in polycythemia vera and essential thrombocythemia.
Topics: Arterial Occlusive Diseases; Aspirin; Clopidogrel; Dipyridamole; Drug Therapy, Combination; Humans; | 2008 |
Hydroxyurea induced acute elevations in liver function tests.
Topics: Aged, 80 and over; Antineoplastic Agents; Chemical and Drug Induced Liver Injury; Humans; Hydroxyure | 2008 |
Hydroxycarbamide associated platelet count oscillations in a patient with polycythaemia vera. A case report and review of the literature.
Topics: Antineoplastic Agents; Female; Humans; Hydroxyurea; Middle Aged; Platelet Count; Polycythemia Vera; | 2008 |
[Development of acute coronary syndrome in three patients with essential thrombocythemia or polycythemia vera].
Topics: Adult; Anticoagulants; Antisickling Agents; Aspirin; Coronary Angiography; Diagnosis, Differential; | 2008 |
Treatment of polycythemia vera with hydroxyurea.
Topics: Acute Disease; Aged; Bone Marrow; Female; Humans; Hydroxyurea; Leukemia; Leukopenia; Male; Middle Ag | 1984 |
Effect of erythropoietin on erythropoietin-responsive cell regeneration in polycythemic mice treated with cyclophosphamide.
Topics: Animals; Cell Division; Cyclophosphamide; Erythropoiesis; Erythropoietin; Female; Hematopoietic Stem | 1981 |
Characterization of hypocholesterolemia in myeloproliferative disease. Relation to disease manifestations and activity.
Topics: Aged; Cholesterol; Cholesterol, HDL; Cholesterol, LDL; Female; Humans; Hydroxyurea; Lipoproteins, HD | 1981 |
Hydroxyurea and sickle cell crisis.
Topics: Anemia, Sickle Cell; Humans; Hydroxyurea; Leukemia; Pain; Polycythemia Vera | 1995 |
[A case for diagnosis: Hydrea pseudo-dermatomyositis].
Topics: Dermatomyositis; Female; Humans; Hydroxyurea; Middle Aged; Polycythemia Vera | 1994 |
Survival and risk of leukaemia in polycythaemia vera and essential thrombocythaemia treated with oral radiophosphorus: are safer drugs available?
Topics: Administration, Oral; Aged; Busulfan; Female; Humans; Hydroxyurea; Leukemia, Myeloid, Acute; Leukemi | 1995 |
Efficacy of alpha interferon and hydroxyurea in late phase refractory myeloproliferative disease.
Topics: Adult; Drug Therapy, Combination; Hematologic Tests; Humans; Hydroxyurea; Interferon-alpha; Leukemia | 1994 |
Nail and skin hyperpigmentation associated with hydroxyurea therapy for polycythemia vera.
Topics: Female; Humans; Hydroxyurea; Hyperpigmentation; Middle Aged; Mouth Diseases; Mouth Mucosa; Nail Dise | 1993 |
Lymphoma transformation in polycythaemia vera treated with hydroxyurea.
Topics: Antineoplastic Combined Chemotherapy Protocols; Biopsy; Bone Marrow; Humans; Hydroxyurea; Liver; Lym | 1993 |
t(8;21) prior to acute leukemia.
Topics: Chromosomes, Human, Pair 21; Chromosomes, Human, Pair 8; Female; Humans; Hydroxyurea; Leukemia, Myel | 1993 |
Hydroxyurea and lower leg ulcers.
Topics: Aged; Female; Humans; Hydroxyurea; Leg Ulcer; Male; Middle Aged; Polycythemia Vera; Primary Myelofib | 1993 |
[Hydroxyurea in the treatment of erythremia].
Topics: Adult; Aged; Chronic Disease; Drug Evaluation; Female; Humans; Hydroxyurea; Male; Middle Aged; Polyc | 1993 |
Leukemogenic risk of hydroxyurea therapy in polycythemia vera, essential thrombocythemia, and myeloid metaplasia with myelofibrosis.
Topics: Acute Disease; Anemia, Refractory, with Excess of Blasts; Busulfan; Cell Transformation, Neoplastic; | 1996 |
Acute myeloid leukemia evolving from polycythemia vera in a patient treated with hydroxyurea.
Topics: Adult; Bone Marrow; Disease Progression; Fatal Outcome; Humans; Hydroxyurea; Leukemia, Monocytic, Ac | 1996 |
[Treatment with hydroxyurea of polycythemia vera in a 11 year-old child].
Topics: Antineoplastic Agents; Child; Hematocrit; Humans; Hydroxyurea; Male; Polycythemia Vera | 1996 |
Management of polycythemia vera with hydroxyurea.
Topics: Adult; Aged; Antineoplastic Agents; Female; Humans; Hydroxyurea; Male; Middle Aged; Polycythemia Ver | 1997 |
APC resistance as an additional thrombotic risk factor in a patient suffering from polycythemia vera and recurrent thrombosis.
Topics: Drug Resistance; Enzyme Activation; Factor V; Hematopoiesis; Heterozygote; Humans; Hydroxyurea; Male | 1997 |
Spurious glycohemoglobin values associated with hydroxyurea treatment.
Topics: Chromatography, High Pressure Liquid; Diabetes Complications; Diabetes Mellitus; Glycated Hemoglobin | 1997 |
Polycythemia vera: a retrospective and reprise.
Topics: Aspirin; Blood Volume; Controlled Clinical Trials as Topic; Female; Hematocrit; History, 19th Centur | 1997 |
Busulfan versus hydroxyurea in the treatment of polycythemia vera (PV) and essential thrombocythemia (ET)
Topics: Antineoplastic Agents; Busulfan; Humans; Hydroxyurea; Immunosuppressive Agents; Polycythemia Vera; R | 1998 |
Platelet transfusion for surgery in the presence of polycythemia vera.
Topics: Aged; Female; Gastrectomy; Hemostasis; Humans; Hydroxyurea; Platelet Transfusion; Polycythemia Vera; | 1998 |
Multiple actinic keratosis and skin tumors secondary to hydroxyurea treatment.
Topics: Aged; Antineoplastic Agents; Busulfan; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Humans; Hydr | 1998 |
Plasma erythropoietin by high-detectability immunoradiometric assay in untreated and treated patients with polycythaemia vera and essential thrombocythaemia.
Topics: Adult; Aged; Aged, 80 and over; Erythropoietin; Female; Hemoglobins; Humans; Hydroxyurea; Immunoradi | 1998 |
Recurrent pyrexia, cough and dyspnoea with hydroxyurea.
Topics: Cough; Dyspnea; Fever; Humans; Hydroxyurea; Male; Middle Aged; Polycythemia Vera; Recurrence | 1998 |
Is hydroxyurea leukemogenic in essential thrombocythemia?
Topics: Acute Disease; Antineoplastic Agents, Alkylating; Bone Marrow; Busulfan; Chromosome Aberrations; Chr | 1998 |
Acute coronary disease in essential thrombocythemia and polycythemia vera.
Topics: Adult; Aged; Aging; Antisickling Agents; Aspirin; Female; Follow-Up Studies; Humans; Hydroxyurea; Ma | 1998 |
Leg ulcers associated with long-term hydroxyurea therapy.
Topics: Aged; Antineoplastic Agents; Female; Humans; Hydroxyurea; Leg Ulcer; Leukemia, Myelogenous, Chronic, | 1998 |
Leukemic transformation in polycythemia Vera. MPD(UK) Study Group.
Topics: Antineoplastic Agents; Humans; Hydroxyurea; Leukemia; Pipobroman; Polycythemia Vera | 1998 |
Hydroxyurea-induced fever and hepatitis.
Topics: Aged; Chemical and Drug Induced Liver Injury; Female; Fever; Humans; Hydroxyurea; Male; Middle Aged; | 1998 |
The effect of interferon alpha on myeloproliferation and vascular complications in polycythemia vera.
Topics: Adult; Aged; Aged, 80 and over; Busulfan; Drug Tolerance; Erysipelas; Erythropoiesis; Female; Hemato | 1999 |
Survival in a patient with polycythaemia vera for over thirty years: implications for treatment decisions in younger patients.
Topics: Adult; Busulfan; Female; Humans; Hydroxyurea; Phlebotomy; Phosphorus Radioisotopes; Polycythemia Ver | 1998 |
How safe is hydroxyurea in the treatment of polycythemia vera?
Topics: Aged; Antisickling Agents; Humans; Hydroxyurea; Middle Aged; Polycythemia Vera | 1999 |
Acute myeloid leukemia occurring in a patient with polycythemia vera in treatment with hydroxyurea.
Topics: Acute Disease; Antisickling Agents; Humans; Hydroxyurea; Leukemia, Myeloid; Male; Middle Aged; Polyc | 1999 |
Polycythaemia vera: bone marrow histopathology under treatment with interferon, hydroxyurea and busulphan.
Topics: Adult; Aged; Aged, 80 and over; Biopsy; Bone Marrow; Busulfan; Follow-Up Studies; Hematopoietic Stem | 2000 |
Hydroxyurea-induced cutaneous ulceration in older patients.
Topics: Aged; Aged, 80 and over; Antineoplastic Agents; Female; Foot Ulcer; Humans; Hydroxyurea; Leukemia, M | 2000 |
Plasma erythropoietin concentrations in polycythaemia vera with special reference to myelosuppressive therapy.
Topics: Adult; Aged; Busulfan; Erythropoietin; Female; Humans; Hydroxyurea; Immunosuppressive Agents; Interf | 2000 |
Hydroxyurea induced skin ulceration in myeloproliferative disorders.
Topics: Aged; Female; Humans; Hydroxyurea; Male; Middle Aged; Myeloproliferative Disorders; Nucleic Acid Syn | 2000 |
Hydroxyurea-induced marked oscillations of platelet counts in patients with polycythemia vera.
Topics: Antisickling Agents; Blood Platelets; Female; Humans; Hydroxyurea; Male; Middle Aged; Platelet Count | 2000 |
The cutaneous side-effects of hydroxyurea.
Topics: Aged; Alopecia; Carcinoma, Squamous Cell; Female; Humans; Hydroxyurea; Keratosis; Polycythemia Vera; | 2000 |
[Leukemic transformation of polycythemia vera after treatment with hydroxyurea and chromosome 17 abnormalities].
Topics: Chromosome Deletion; Chromosomes, Human, Pair 17; Female; Humans; Hydroxyurea; Leukemia, Myeloid, Ac | 1999 |
Polycythemia vera in a patient with the human immunodeficiency virus: a case report.
Topics: Anti-HIV Agents; Antineoplastic Agents; Diagnosis, Differential; Drug Administration Schedule; Drug | 2000 |
Myeloproliferative syndromes. Current opinions from the European Hematology Association Working Group on Myeloproliferative Disorders.
Topics: Aspirin; Bone Marrow Examination; Clinical Trials as Topic; Clone Cells; Congresses as Topic; Diseas | 2001 |
[Hydroxyurea--is it a harmless drug in Vaquez disease?]].
Topics: Aged; Alopecia; Combined Modality Therapy; Cystitis; Erectile Dysfunction; Female; Fever; Follow-Up | 2001 |
[Chronic progressive polycythemia and thrombocytosis].
Topics: Aged; Combined Modality Therapy; Female; Humans; Hydroxyurea; Phlebotomy; Polycythemia Vera; Thrombo | 2001 |
[Polycythemia vera--current status of therapy].
Topics: Humans; Hydroxyurea; Phlebotomy; Polycythemia Vera; Treatment Outcome | 2001 |
Hydroxyurea and periodicity in myeloproliferative disease.
Topics: Adult; Aged; Antineoplastic Agents; Blood Cell Count; Busulfan; Female; Hemoglobins; Humans; Hydroxy | 2001 |
Subcutaneous extramedullary hematopoiesis in a patient with secondary myelofibrosis following polycythemia vera.
Topics: Aged; Female; Hematopoiesis, Extramedullary; Humans; Hydroxyurea; Megakaryocytes; Myeloid Cells; Pol | 2001 |
Comparative genomic hybridization in polycythemia vera and essential thrombocytosis patients.
Topics: Aged; Aged, 80 and over; Chromosome Aberrations; Female; Humans; Hydroxyurea; Male; Middle Aged; Nuc | 2001 |
Leeching as initial treatment in a cat with polycythaemia vera.
Topics: Animals; Cat Diseases; Cats; Enzyme Inhibitors; Female; Hydroxyurea; Leeching; Phlebotomy; Polycythe | 2001 |
[Hydroxyurea-induced leg ulcers in patients with chronic myeloproliferative disorders].
Topics: Aged; Antineoplastic Agents; Drug Eruptions; Female; Humans; Hydroxyurea; Leg Ulcer; Leukemia, Myelo | 2001 |
Leukemic transformation of polycythemia vera after treatment with hydroxyurea with abnormalities of chromosome 17.
Topics: Antineoplastic Agents; Bone Marrow Cells; Chromosome Aberrations; Chromosomes, Human, Pair 17; Disea | 2001 |
Replication status in leukocytes of treated and untreated patients with polycythemia vera and essential thrombocytosis.
Topics: Adult; Aged; Antisickling Agents; Cell Count; Cell Division; DNA Replication; Female; Humans; Hydrox | 2002 |
Unusually prolonged survival of a case of acute megakaryoblastic leukemia secondary to long-standing polycythemia vera.
Topics: Bone Marrow; Combined Modality Therapy; Disease Progression; Erythrocyte Transfusion; Female; Humans | 2002 |
Polycythemia vera in a 12-year-old girl: a case report.
Topics: Aspirin; Child; Drug Therapy, Combination; Female; Hemoglobins; Humans; Hydroxyurea; Leukocyte Count | 2002 |
[A hydroxyurea-induced leg ulceration].
Topics: Antineoplastic Agents; Drug Eruptions; Female; Humans; Hydroxyurea; Leg Ulcer; Middle Aged; Polycyth | 2001 |
Cytostatic treatment of polycythaemia rubra vera. Comparison of the effects of some cytostatics in 100 patients in a period of five years.
Topics: Adolescent; Adult; Aged; Antibiotics, Antineoplastic; Drug Evaluation; Female; Humans; Hydroxyurea; | 1975 |
Pruritus secondary to hydroxyurea therapy in a woman with polycythemia vera.
Topics: Aged; Aged, 80 and over; Female; Humans; Hydroxyurea; Polycythemia Vera; Pruritus | 1992 |
[Primary polycythemia].
Topics: Bloodletting; Erythroid Precursor Cells; Erythropoiesis; Female; Humans; Hydroxyurea; Interferon Typ | 1991 |
Chronic myelomonocytic leukemia transformation in polycythemia vera.
Topics: Aged; Bone Marrow Examination; Humans; Hydroxyurea; Leukemia, Myelomonocytic, Chronic; Leukocyte Cou | 1991 |
Clinical significance of serum pro-collagen III in chronic myeloproliferative disorders.
Topics: Aged; Bloodletting; Humans; Hydroxyurea; Myeloproliferative Disorders; Polycythemia; Polycythemia Ve | 1990 |
Leukemic transformation in polycythemia vera: analysis of risk factors.
Topics: Acute Disease; Female; Humans; Hydroxyurea; Leukemia; Male; Middle Aged; Polycythemia Vera; Retrospe | 1990 |
The effect of hydroxyurea on hemoglobin F in patients with myeloproliferative syndromes.
Topics: Adult; Aged; Erythrocyte Indices; Female; Fetal Hemoglobin; Humans; Hydroxyurea; Male; Middle Aged; | 1985 |
Decreased natural killer (NK) activity in patients with myeloproliferative disorders.
Topics: Bloodletting; Humans; Hydroxyurea; Interferon Type I; Interleukin-2; Killer Cells, Natural; Myelopro | 1989 |
Management of polycythaemia vera, essential thrombocythaemia and myelofibrosis with hydroxyurea.
Topics: Drug Evaluation; Humans; Hydroxyurea; Platelet Count; Polycythemia Vera; Primary Myelofibrosis; Thro | 1988 |
Small intestinal myeloid metaplasia.
Topics: Aged; Female; Hematopoiesis, Extramedullary; Humans; Hydroxyurea; Intestinal Diseases; Intestine, Sm | 1988 |
Acute leukemia in polycythemia vera.
Topics: Acute Disease; Antigens, Neoplasm; Bloodletting; Chlorambucil; Chromosome Aberrations; Chromosome Di | 1986 |
Hypereosinophilic syndrome associated with polycythemia vera.
Topics: Eosinophilia; Female; Humans; Hydroxyurea; Middle Aged; Polycythemia Vera; Primary Myelofibrosis; Re | 1986 |
Long-term management of polycythemia vera with hydroxyurea: a progress report.
Topics: Drug Administration Schedule; Humans; Hydroxyurea; Leukemia; Polycythemia Vera; Thrombosis | 1986 |
Hydroxyurea in the treatment of polycythemia vera: a prospective study of 100 patients over a 20-year period.
Topics: Adult; Aged; Aged, 80 and over; Blood Cell Count; Bloodletting; Combined Modality Therapy; Female; H | 1987 |
Treatment of polycythemia vera with hydroxyurea.
Topics: Aged; Bone Marrow; Follow-Up Studies; Hematocrit; Humans; Hydroxyurea; Platelet Count; Polycythemia | 1986 |
Observations with 5-hydroxyurea in the management of polycythaemia vera.
Topics: Adult; Aged; Female; Humans; Hydroxyurea; Male; Middle Aged; Polycythemia Vera; Remission, Spontaneo | 1972 |
[Choice of treatment in polycythemia vera. 1. Efficacy of chemotherapy].
Topics: Chlorambucil; Humans; Hydroxyurea; Melphalan; Phosphorus Isotopes; Polycythemia Vera; Remission, Spo | 1973 |
[Experience with the 5-hydroxyurea therapy of polycythemia rubra vera].
Topics: Adult; Female; Humans; Hydroxyurea; Male; Middle Aged; Polycythemia Vera | 1972 |