prednisone and Nausea

prednisone has been researched along with Nausea in 86 studies

Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.
prednisone : A synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid.

Nausea: An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.

Research

Studies (86)

Authors

Clinical Trials (9)

Trial Overview

Trial Outcomes

Change From Baseline to End of Treatment in the Global Health Status Score of the European Organization for Research and Treatment of Cancer (EORTC) 30-item Core Quality of Life Questionnaire (QLQ-C30)

EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). This outcome reports the global health status on a scale of 0-100 with a high score for the global health status/QOL represents a high quality of life. (NCT00877006)
Timeframe: Day 1 (prior to treatment), 32 weeks

Kaplan-Meier Estimate for Duration of Response (DOR)

DOR was defined as the time from first response (CR or PR) to disease progression or relapse, or death due to any cause. (NCT00877006)
Timeframe: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)

Kaplan-Meier Estimate for Event-free Survival (EFS)

"EFS was defined as the time from randomization to treatment failure, disease progression or relapse, other malignancies, or death from any cause, whichever occurred first.~Treatment failure was defined as failure to achieve a CR or PR after 6 cycles of treatment. If a patient failed to achieve CR or PR by the time of data analysis or early withdrawal, the treatment failure date was set at 126 days (6 cycles of treatment) after randomization or the new anticancer treatment date, whichever is earlier." (NCT00877006)
Timeframe: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)

Kaplan-Meier Estimate for Progression-free Survival (PFS)

PFS was defined as the time from randomization to disease progression or relapse, or death from any cause, whichever occurred first. (NCT00877006)
Timeframe: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)

Overall Survival (OS)

OS was defined as the time from randomization to death from any cause. (NCT00877006)
Timeframe: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)

Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period

"Relapsed disease (after CR) and progressive disease (PD) (after PR or SD):~Lymph nodes were considered abnormal if the long axis was greater than 1.5 cm. Lymph nodes with a long axis of 1.1 to 1.5 cm were considered abnormal if its short axis was greater than 1.0 cm.~In patients with no prior history of pulmonary lymphoma, new lung nodules identified by CT require histologic confirmation.~>= 50% increase from nadir in sum of the products of the greatest diameters (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must have increased by 2: 50% and to a size of 1.5 cm by 1.5 cm, or more than 1.5 cm in the long axis~other conditions as specified in the protocol" (NCT00877006)
Timeframe: Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period

Percentage of Participants With Complete Response (CR) at End of Treatment Period

CR=complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present pretherapy; protocol-specified positron emission tomography (PET) scan assessment criteria; (if the spleen and/or liver were enlarged on the basis of physical examination and/or anatomic imaging before treatment) the liver and/or spleen were considered normal size on physical examination and by anatomic imaging after therapy, with disappearance of all nodules related to lymphoma; (if the bone marrow was involved by lymphoma before treatment) the infiltrate must have cleared on subsequent bone marrow biopsies. (NCT00877006)
Timeframe: 6 to 8 21 or 28-day cycles (18-32 weeks)

Percentage of Participants With Overall Response at End of Treatment Period

Overall Response=participants with Complete Remission (CR) + those with Partial Remission (PR). CR=see Outcome Measure 1 for details. PR= at least a 50% decrease in the sum of the product of the greatest diameters (SPD) of up to 6 of the largest dominant nodes/masses; at least a 50% decrease in the SPD of hepatic and splenic nodules in their greatest transverse diameter; no increase in the size of the liver, spleen, and other nodes; no measurable disease in organs other than the liver or spleen; no new sites of disease; protocol-specified PET scan and bone marrow criteria. (NCT00877006)
Timeframe: 6 to 8 21 or 28-day cycles (18-32 weeks)

Clinically Significant Abnormal Vital Signs

(NCT00877006)
Timeframe: 32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)

Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period

Participants' ECOG Performance Status was evaluated at the end of treatment as improved, stayed the same, or worsened from baseline (see Baseline Characteristics for ECOG Performance Status). (NCT00877006)
Timeframe: Week 32

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period

AE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. An AE can, therefore, be any unfavorable and unintended physical sign, symptom, or laboratory parameter that develops or worsens in severity during the course of the study, or significant worsening of the disease under study (or any concurrent disease), whether or not considered related to the study drug. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). SAE=an adverse event occurring at any dose that results in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity (a substantial disruption of one's ability to conduct normal life functions), a congenital anomaly/birth defect, or other important medical event. (NCT00877006)
Timeframe: 32 weeks

Participants Who Died At the End of the Treatment Period or the Long-Term Follow-up Period

Death is due to any cause. Data are broken out by patients who died within 30 days of the last dose of study medications, and those who died greater than 30 days of the last dose of study medications. (NCT00877006)
Timeframe: Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period

Potentially Clinically Significant Abnormal Weight

Participants were weighed at Baseline and at Endpoint (Week 32); those participants with an increase or decrease of >=10% were considered potentially clinically significant. (NCT00877006)
Timeframe: Baseline, Week 32

Therapeutic Classification of Concomitant Medications

(NCT00877006)
Timeframe: 32 weeks

Therapeutic Classification of Prior Medications

(NCT00877006)
Timeframe: prior to start of treatment

Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results

Clinical laboratory data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for serum chemistry test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and laboratory test across all cycles). (NCT00877006)
Timeframe: 32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)

Worst Overall CTCAE Grade for Hematology Laboratory Test Results

Hematology test data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for hematology test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and hematology test across all cycles). (NCT00877006)
Timeframe: 32 weeks (conducted at screening, Day 1 of each cycle, weekly during treatment, and at the end-of-treatment visit)

Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)

The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma. (NCT01777152)
Timeframe: Up to 8.34 months

Objective Response Rate (ORR) Per IRF at End of Treatment

The count of participants with CR or partial response (PR) per IRF following the completion of study treatment (at end of treatment or the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma. (NCT01777152)
Timeframe: Up to 8.34 months

Overall Survival (OS)

The time from randomization to death due to any cause. (NCT01777152)
Timeframe: Up to 90 months

Progression-free Survival Per Independent Review Facility (IRF)

The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first. (NCT01777152)
Timeframe: Up to 60 months

Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)

The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first. (NCT01777152)
Timeframe: Up to 60 months

Incidence of Adverse Events (AEs)

Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. (NCT01777152)
Timeframe: Up to 8.28 months

Incidence of Laboratory Abnormalities

Number of participants who experienced a Grade 3 or higher laboratory toxicity. (NCT01777152)
Timeframe: Up to 8.28 months

Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma

Toxicity assessed using NCI-CTC v. 3.0 (NCT00295932)
Timeframe: 2 years

Maximum Tolerated Dose

Maximum tolerated dose of Bortezomib in combination with Rituximab, Cyclophosphamide and Prednisone in Phase I participants (NCT00295932)
Timeframe: 2 years

Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points.

Assess and compare the patient reported and parent proxy cognitive problems (child + teen) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. (NCT00145600)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)

Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points.

Assess and compare the patient reported and parent proxy communication quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. (NCT00145600)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)

Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points.

Assess and compare the patient reported and parent proxy emotional quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. (NCT00145600)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).

Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points.

Assess and compare the patient reported and parent proxy nausea quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. (NCT00145600)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)

Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points.

Assess and compare the patient reported and parent proxy pain and hurt quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. (NCT00145600)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).

Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points.

Assess and compare the patient reported and parent proxy Peds QL4 (composite) quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. (NCT00145600)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).

Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points.

Assess and compare the patient reported and parent proxy PedsQL3 (composite) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. (NCT00145600)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)

Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points.

Assess and compare the patient reported and parent proxy perceived physical appearance quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. (NCT00145600)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)

Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points.

Assess and compare the patient reported and parent proxy physical quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. (NCT00145600)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).

Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points.

Assess and compare the patient reported and parent proxy procedural anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. (NCT00145600)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)

Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points.

Assess and compare the patient reported and parent proxy psychosocial quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. (NCT00145600)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).

Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points.

Assess and compare the patient reported and parent proxy school quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. (NCT00145600)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).

Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points.

Assess and compare the patient reported and parent proxy social quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. (NCT00145600)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).

Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points.

Assess and compare the patient reported and parent proxy treatment anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. (NCT00145600)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)

Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points.

Assess and compare the patient reported and parent proxy worry quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life. (NCT00145600)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)

Event-free Survival Probability by Risk Group

Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier (KM) method with a 95% confidence interval calculated using the Greenwood's formula. (NCT00145600)
Timeframe: Median 6.4 year follow-up

Event-free Survival Probability by Risk Group at 10-year Follow-Up

Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier (KM) method with a 95% confidence interval calculated using the with Greenwood's formula. (NCT00145600)
Timeframe: 10-year follow-up after protocol enrollment

Reviews

2 reviews available for prednisone and Nausea

Trials

26 trials available for prednisone and Nausea

Other Studies

58 other studies available for prednisone and Nausea