niacinamide and Adverse Drug Event

niacinamide has been researched along with Adverse Drug Event in 48 studies

nicotinamide : A pyridinecarboxamide that is pyridine in which the hydrogen at position 3 is replaced by a carboxamide group.

Research

Studies (48)

Authors

Clinical Trials (11)

Trial Overview

Trial Outcomes

6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16

6-minute walking distance (6MWD) is a measure for the objective evaluation of a participant's functional exercise capacity. (NCT00855465)
Timeframe: Baseline and week 16

Alanine Aminotransferase (ALT) - Change From Baseline to Week 16

Alanine Aminotransferase (ALT) is a standard clinical chemistry parameter. Normal range: 0 to 45 U/L. (NCT00855465)
Timeframe: Baseline and week 16

Alkaline Phosphatase (AP) - Change From Baseline to Week 16

Alkaline phosphatase (AP) is a standard clinical chemistry parameter. Normal range: 40 to 129 U/L (males), 35 to 104 U/L (females) (NCT00855465)
Timeframe: Baseline and week 16

All Caused Mortality

"All cause mortality (including cardiovascular mortality) was one component of the composite endpoint time to clinical worsening." (NCT00855465)
Timeframe: At visit 6 (week 16)

Arterial Partial Oxygen Pressure (PaO2) - Change From Baseline to Week 16

Arterial partial pressure of oxygen (PaO2) is performed as part of the capillary or arterial blood gas analysis. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn. (NCT00855465)
Timeframe: Baseline and week 16

Arterial Partial Pressure of Carbon Dioxide (PaCO2) - Change From Baseline to Week 16

Arterial partial pressure of carbon dioxide (PaCO2) is performed as part of the capillary or arterial blood gas analysis. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn. (NCT00855465)
Timeframe: Baseline and week 16

Aspartate Aminotransferase (AST) - Change From Baseline to Week 16

Aspartate Aminotransferase (AST) is a standard clinical chemistry parameter. Normal range: 0 to 41 U/L. (NCT00855465)
Timeframe: Baseline and week 16

Bilirubin - Change From Baseline to Week 16

Bilirubin is a standard clinical chemistry parameter. Normal range: 0.1 to 1.2 mg/dL (NCT00855465)
Timeframe: Baseline and week 16

Borg CR 10 Scale - Change From Baseline to Week 16

"The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant's exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 (Nothing at all) to 10 (Extremely strong - Maximal)." (NCT00855465)
Timeframe: Baseline and week 16

Cardiac Index (CI) - Change From Baseline to Week 16

The cardiac index (CI) is a calculated hemodynamic parameter. CI is derived from the directly measured parameters cardiac output (CO), divided by the body surface area (BSA). BSA is a calculated parameter, using the subject's height and weight in the DuBois formula. Formula: BSA = (W [kg]*0.425)*(H [cm]*0.725)*0.007184 (m^2) (NCT00855465)
Timeframe: Baseline and week 16

Creatine Kinase (CK) - Change From Baseline to Week 16

Creatine Kinase is a standard clinical chemistry parameter. Normal range: 35 to 232 U/L (males), 26 to 145 U/L (females) (NCT00855465)
Timeframe: Baseline and week 16

Creatinine - Change From Baseline to Week 16

Creatinine is a standard clinical chemistry parameter. Normal range: 0.25 to 1.20 mg/dL (males), 0.46 to 1.00 mg/dL (females) (NCT00855465)
Timeframe: Baseline and week 16

Creatinine Clearance - Change From Baseline to Week 16

Creatinine clearance is a standard clinical chemistry parameter. Normal range: 90 to 140 mL/min (males), 80 to 125 mL/min (females) (NCT00855465)
Timeframe: Baseline and week 16

Cystatin C - Change From Baseline to Week 16

Cystatin C is a biomarker. Normal range: 0.53 to 1.01 ng/mL (NCT00855465)
Timeframe: Baseline and week 16

Diastolic Blood Pressure (DBP) - Change From Baseline to Week 16

Diastolic systemic arterial blood pressure (DBP) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: <= 110 mmHg. (NCT00855465)
Timeframe: Baseline and week 16

EQ-5D Utility Score - Change From Baseline to Week 16

EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions). (NCT00855465)
Timeframe: Baseline and week 16

Erythrocytes (RBC) - Change From Baseline to Week 16

Erythrocytes (red blood cells, RBC) is a standard clinical hematology parameter. Normal range: 4.6 to 5.8*10^12 cells/L (males), 4.1 to 5.2*10^12 cells/L (females) (NCT00855465)
Timeframe: Baseline and week 16

Heart Rate (HR) - Change From Baseline to Week 16

Heart rate (HR) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: 50 -105 beats per minute (bpm) at rest. (NCT00855465)
Timeframe: Baseline and week 16

Hematocrit - Change From Baseline to Week 16

Hematocrit is a standard clinical hematology parameter. Normal range: 40 to 52% (males), 36 to 46% (females) (NCT00855465)
Timeframe: Baseline and week 16

Hemoglobin - Change From Baseline to Week 16

Hemoglobin is a standard clinical hematology parameter. Normal range: 13.5 to 17.5 g/dL (males), 12.0 to 16.0 g/dL (females) (NCT00855465)
Timeframe: Baseline and week 16

Leukocytes (WBC) - Change From Baseline to Week 16

Leukocytes (white blood cells, WBC) is a standard clinical hematology parameter. Normal range: 4.0 to 10.7*10^9 cells/L (NCT00855465)
Timeframe: Baseline and week 16

Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 16

The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The LPH total score can range from 0 (best) to 105 (worst). (NCT00855465)
Timeframe: Baseline and week 16

Lymphocytes - Change From Baseline to Week 16

Total lymphocytes is a standard clinical hematology parameter. Normal range: 1.0 to 4.0*10^9 cells/L (NCT00855465)
Timeframe: Baseline and week 16

Mean PR Duration (PRmean) - Change From Baseline to Week 16

PR duration was evaluated as part of the 12-lead electrocardiogram. electrocardiograms (ECGs) were recorded after the participant had been at rest for 15 minutes in a supine position. (NCT00855465)
Timeframe: Baseline and week 16

Mean Pulmonary Artery Pressure (PAPmean) - Change From Baseline to Week 16

Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization. (NCT00855465)
Timeframe: Baseline and week 16

Mean QRS Duration (QRSmean) - Change From Baseline to Week 16

QRS duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position. (NCT00855465)
Timeframe: Baseline and week 16

Mean QT Duration (QTmean) - Change From Baseline to Week 16

QT duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position. (NCT00855465)
Timeframe: Baseline and week 16

Mean QTcB Duration (Bazett's Correction Formula, QTcB) - Change From Baseline to Week 16

Bazett-corrected QTcB duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position. (NCT00855465)
Timeframe: Baseline and week 16

Mean QTcF Duration (Fridericia's Correction Formula, QTcF) - Change From Baseline to Week 16

Fridericia-corrected QTcF duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position. (NCT00855465)
Timeframe: Baseline and week 16

Mean RR Duration (RRmean) - Change From Baseline to Week 16

RR duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position. (NCT00855465)
Timeframe: Baseline and week 16

Mean Ventricular Rate (VRmean) - Change From Baseline to Week 16

Ventricular rate was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position (NCT00855465)
Timeframe: Baseline and week 16

N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 16

N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure. (NCT00855465)
Timeframe: Baseline and week 16

Neutrophils - Change From Baseline to Week 16

Neutrophils is a standard clinical hematology parameter. Normal range: 1.6 to 7.4*10^9 cells/L (NCT00855465)
Timeframe: Baseline and week 16

Oxygen Saturation (SaO2) - Change From Baseline to Week 16

Oxygen saturation (SaO2) is measured as part of the capillary or arterial blood gas analysis. Normal blood oxygen saturation is considered 95-100 percent. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn. (NCT00855465)
Timeframe: Baseline and week 16

Potassium - Change From Baseline to Week 16

Potassium is a standard clinical chemistry parameter. Normal range: 3.5 to 5.3 mmol/L (NCT00855465)
Timeframe: Baseline and week 16

Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16

The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO (NCT00855465)
Timeframe: Baseline and week 16

Systolic Blood Pressure (SBP) - Change From Baseline to Week 16

Systolic systemic arterial blood pressure (SBP) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: 95 - 180 mmHg. (NCT00855465)
Timeframe: Baseline and week 16

Triacylglycerol Lipase - Change From Baseline to Week 16

Triacylglycerol lipase is a standard clinical chemistry parameter. Normal range: 7 to 60 U/L (NCT00855465)
Timeframe: Baseline and week 16

Urate - Change From Baseline to Week 16

Urate is a standard clinical chemistry parameter. Normal range: 4.0 to 8.5 mg/dL (males, 16-59 years), 3.4 to 8.7 mg/dL (males, >60 years) 2.5 to 7.5 mg/dL (females) (NCT00855465)
Timeframe: Baseline and week 16

Urea (BUN) - Change From Baseline to Week 16

Urea (blood urea nitrogen, BUN) is a standard clinical chemistry parameter. Normal range: 4 to 25 mg/dL (NCT00855465)
Timeframe: Baseline and week 16

Percentage of Participants With Clinical Worsening

"The combined endpoint time to clinical worsening, made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; rescue endarterectomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH." (NCT00855465)
Timeframe: At week 16

World Health Organization (WHO) Functional Class - Change From Baseline to Week 16

The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH. (NCT00855465)
Timeframe: Baseline and week 16

Overall Survival

Time between the first day of treatment to the days of death. (NCT00098254)
Timeframe: 17 months

Progression Free Survival

"Time between the first day of treatment to the day of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions.~Appearance of one or more new lesions and/or unequivocal progressions of existing non-target lesions." (NCT00098254)
Timeframe: 17 months

Response Rate

Percentage of participants with response rate = CR + PR. Response will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR (complete response) is the disappearance of all target lesions; PR (partial response) is a 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) is a 20% increase in the sum of the longest diameter of target lesions; and SD (stable disease) are small changes that do not meet the above criteria. Please see the Protocol Link module for additional information about RECIST if desired. (NCT00098254)
Timeframe: 17 months

The Number of Participants With Adverse Events

Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00098254)
Timeframe: 5 1/2 years

Correlation of Response to Treatment With KRAS Mutational Status

Mutational analysis of these genes was performed on paraffin-imbedded tissue blocks from prior pathologic specimens. Disease control rate was correlated with KRAS mutational status. Disease control rate was defined as complete remission (CR) + partial remission (PR)+ stable disease (SD). (NCT00098254)
Timeframe: 42 months

Cytokine Levels

Serial plasma samples were collected from all patients and cytokine levels were measured. The concentrations of the cytokines were determined with recombinant standards and expressed as picograms per milliliter (pg/ml). (NCT00098254)
Timeframe: 54 days

Overall Survival Associated With Basic Fibroblast Growth Factor (bFGF)

Serum plasma is collected at the beginning of each cycle during the course of the study and analyzed by the enzyme-linked immunosorbent assay (ELISA). (NCT00098254)
Timeframe: 42 months

Overall Survival Reported Separately for Participants With a Change in PLGF Below 11 pg/ml and Above 12 pg/ml

Difference in placental derived growth factor (PLGF) between day 28 and day 0 of < 11 pg/ml vs. > 12 pg/ml. (NCT00098254)
Timeframe: 17 months

Percentage of Participants With an Increase or Decrease in the Reverse Contrast Transfer Rate (Kep), Forward Contrast Transfer Rate (Ktrans), and Extravascular Fraction (Ve) With the Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI)

DCE-MRI was used to evaluate changes (e.g. decrease/increase in Ve, Ktrans, Kep value) in vascularity and quality of index lesions to provide early indication of treatment effect before changes in size can be perceived on CT. Changes were reflected in a decrease/increase of Ve, Ktrans, or Kep (Kep, Ve, Ktrans measurements at day 0, day 14 and the difference between the day 14 and the day 0 measurements (day 14-day 0). (NCT00098254)
Timeframe: 59 months

Progression Free Survival Associated With Basic Fibroblast Growth Factor (bFGF)

Serum plasma is collected at the beginning of each cycle during the course of the study and analyzed by the enzyme-linked immunosorbent assay (ELISA). (NCT00098254)
Timeframe: 17 months

Reviews

6 reviews available for niacinamide and Adverse Drug Event

Trials

14 trials available for niacinamide and Adverse Drug Event

Other Studies

28 other studies available for niacinamide and Adverse Drug Event