Trial · NCT00877006
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete Response (CR) at End of Treatment Period | 6 to 8 21 or 28-day cycles (18-32 weeks) | Evaluable Analysis Set: treated participants with a baseline and \>=1 post-baseline response evaluation (based on computed tomography/magnetic resonance imaging \[CT/MRI\] or positron emission tomography \[PET\] and clinical data), or who discontinued treatment due to progressive disease and had no major protocol violations. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Overall Response at End of Treatment Period | 6 to 8 21 or 28-day cycles (18-32 weeks) | Evaluable Analysis Set: treated participants with a baseline and \>=1 post-baseline response evaluation (based on computed tomography/magnetic resonance imaging \[CT/MRI\] or positron emission tomography \[PET\] and clinical data), or who discontinued treatment due to progressive disease and had no major protocol violations. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period | 32 weeks | Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen. | participants | NUMBER |
| SECONDARY | Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results | 32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit) | Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and who had a post-baseline assessment. | participants | NUMBER |
| SECONDARY | Worst Overall CTCAE Grade for Hematology Laboratory Test Results | 32 weeks (conducted at screening, Day 1 of each cycle, weekly during treatment, and at the end-of-treatment visit) | Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and who had an assessment. | participants | NUMBER |
| SECONDARY | Clinically Significant Abnormal Vital Signs | 32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit) | Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and had baseline and post-baseline values. | participants | NUMBER |
| SECONDARY | Potentially Clinically Significant Abnormal Weight | Baseline, Week 32 | Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen with a baseline and post-baseline weight. | participants | NUMBER |
| SECONDARY | Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period | Week 32 | Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and with baseline and post-baseline values. | participants | NUMBER |
| SECONDARY | Therapeutic Classification of Prior Medications | prior to start of treatment | Safety Analysis Set: all participants randomly assigned to a treatment group | participants | NUMBER |
| SECONDARY | Therapeutic Classification of Concomitant Medications | 32 weeks | Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen. | participants | NUMBER |
| SECONDARY | 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) | Day 1 (prior to treatment), 32 weeks | The set of randomized participants (intent-to-treat) consisting of all patients randomly assigned to treatment, and who had data at both timepoints. | units on a scale | MEAN |
| SECONDARY | Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period | Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period | Randomized patients: the set of randomized patients (intent-to-treat) consists of all patients randomly assigned to treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Kaplan-Meier Estimate for Progression-free Survival (PFS) | Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period) | Randomized patients | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimate for Event-free Survival (EFS) | Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period) | Randomized patients | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimate for Duration of Response (DOR) | Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period) | Randomized patients with complete response (CR) or partial response (PR) | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period) | Randomized patients | months | MEDIAN |
| SECONDARY | Participants Who Died At the End of the Treatment Period or the Long-Term Follow-up Period | Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period | Randomized patients: the set of randomized patients (intent-to-treat) consists of all patients randomly assigned to treatment. | Participants | COUNT_OF_PARTICIPANTS |
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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GET https://conductscience.org/api/trials/v1/NCT00877006/outcomes