Trial · NCT01163253
Registered outcomes78
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 78
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose (up to 67 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. |
| Primary | Number of Adverse Events (AEs) by Severity | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories: a) mild: AEs did not interfere with participant's usual function; b) moderate: AEs interfered to some extent with participant's usual function; c) severe: AEs interfered significantly with participant's usual function. |
| Primary | Number of Participants With Laboratory Abnormalities | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) | Abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell \<0.8\*lower limit of normal \[LLN\]; reticulocyte\<0.5\*LLN,\>1.5\*ULN; platelets\<0.5\*LLN,\>1.75\* upper limit of normal \[ULN\]; WBC\<0.6\*LLN, \>1.5\*ULN; lymphocytes, neutrophils, basophils, eosinophils, monocytes\<0.8\*LLN; \>1.2\*ULN; coagulation (prothrombin \[PT\], PT ratio\>1.1\*ULN) liver function (bilirubin\>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT\>0.3\*ULN, protein, albumin\<0.8\*LLN; \>1.2\*ULN, globulin\<0.5\*LLN; \>1.5\*ULN); renal function (blood urea nitrogen, creatinine\>1.3\*ULN); electrolytes(sodium\<0.95\* LLN; \>1.05\* ULN, potassium, chloride, calcium, bicarbonate\<0.9\*LLN; \>1.1\*ULN), chemistry (glucose\<0.6\*LLN; \>1.5\* ULN), urinalysis (pH \<4.5;\>8, glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte esterase\>=1; RBC, WBC\>=20); lipids (cholesterol \[C\], LDL-C \>1.3\*ULN, HDL-C\<0.8\*LLN, triglycerides\>1.3\* ULN), hormones(T4, T3, T4, TSH\<0.8\* LLN; \>1.2\* ULN). |
| Primary | Change From Baseline in Hemoglobin Level at Month 1 | Baseline, Month 1 | |
| Primary | Change From Baseline in Hemoglobin Level at Month 3 | Baseline, Month 3 | |
| Primary | Change From Baseline in Hemoglobin Level at Month 6 | Baseline, Month 6 | |
| Primary | Change From Baseline in Hemoglobin Level at Month 12 | Baseline, Month 12 | |
| Primary | Change From Baseline in Hemoglobin Level at Month 24 | Baseline, Month 24 | |
| Primary | Change From Baseline in Hemoglobin Level at Month 36 | Baseline, Month 36 | |
| Primary | Change From Baseline in Hemoglobin Level at Month 48 | Baseline, Month 48 | |
| Primary | Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 | Baseline, Month 1 | |
| Primary | Change From Baseline in Lymphocyte and Neutrophil Count at Month 3 | Baseline, Month 3 | |
| Primary | Change From Baseline in Lymphocyte and Neutrophil Count at Month 6 | Baseline, Month 6 | |
| Primary | Change From Baseline in Lymphocyte and Neutrophil Count at Month 12 | Baseline, Month 12 | |
| Primary | Change From Baseline in Lymphocyte and Neutrophil Count at Month 24 | Baseline, Month 24 | |
| Primary | Change From Baseline in Lymphocyte and Neutrophil Count at Month 36 | Baseline, Month 36 | |
| Primary | Change From Baseline in Lymphocyte and Neutrophil Count at Month 48 | Baseline, Month 48 | |
| Primary | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Baseline, Month 1 | |
| Primary | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3 | Baseline, Month 3 | |
| Primary | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6 | Baseline, Month 6 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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