Trial · NCT01163253
Outcomes78
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 78
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | Safety analysis set included all participants who received at least 1 dose of study drug. | participants | NUMBER |
| 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) | Safety analysis set included all participants who received at least 1 dose of study drug. | adverse events | NUMBER |
| 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) | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | participants | NUMBER |
| PRIMARY | Change From Baseline in Hemoglobin Level at Month 1 | Baseline, Month 1 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies participants evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | gram per deciliter (g/dL) | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin Level at Month 3 | Baseline, Month 3 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | g/dL | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin Level at Month 6 | Baseline, Month 6 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | g/dL | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin Level at Month 12 | Baseline, Month 12 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | g/dL | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin Level at Month 24 | Baseline, Month 24 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | g/dL | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin Level at Month 36 | Baseline, Month 36 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | g/dL | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin Level at Month 48 | Baseline, Month 48 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | g/dL | MEAN |
| PRIMARY | Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 | Baseline, Month 1 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | 1000 cells/mm^3 | MEAN |
| PRIMARY | Change From Baseline in Lymphocyte and Neutrophil Count at Month 3 | Baseline, Month 3 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | 1000 cells/mm^3 | MEAN |
| PRIMARY | Change From Baseline in Lymphocyte and Neutrophil Count at Month 6 | Baseline, Month 6 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | 1000 cells/mm^3 | MEAN |
| PRIMARY | Change From Baseline in Lymphocyte and Neutrophil Count at Month 12 | Baseline, Month 12 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | 1000 cells/mm^3 | MEAN |
| PRIMARY | Change From Baseline in Lymphocyte and Neutrophil Count at Month 24 | Baseline, Month 24 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | 1000 cells/mm^3 | MEAN |
| PRIMARY | Change From Baseline in Lymphocyte and Neutrophil Count at Month 36 | Baseline, Month 36 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | 1000 cells/mm^3 | MEAN |
| PRIMARY | Change From Baseline in Lymphocyte and Neutrophil Count at Month 48 | Baseline, Month 48 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | 1000 cells/mm^3 | MEAN |
| 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 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | milligram per deciliter (mg/dL) | MEAN |
| 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 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | mg/dL | MEAN |
| 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 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | mg/dL | MEAN |
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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