Trial · NCT00829166
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 PD or Death as Assessed by an Independent Review Committee (IRC) | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | percentage of participants | NUMBER |
| PRIMARY | Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint) | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Months | MEDIAN |
| PRIMARY | Percentage of Participants Who Died: Second Interim Analysis | From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | percentage of participants | NUMBER |
| PRIMARY | Overall Survival: Second Interim Analysis (Co-primary Endpoint) | From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Months | MEDIAN |
| PRIMARY | Percentage of Participants Who Died: Final Analysis | From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | percentage of participants | NUMBER |
| PRIMARY | Overall Survival: Final Analysis | From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Months | MEDIAN |
| PRIMARY | Percentage of Participants Who Were Alive at Year 1 | Year 1 | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Were Alive at Year 2 | Year 2 | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With PD or Death as Assessed by the Investigator | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | percentage of participants | NUMBER |
| SECONDARY | PFS as Assessed by the Investigator | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response (OR) as Assessed by an IRC | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at baseline were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Duration of Objective Response (DOR) as Assessed by an IRC | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with an objective response were included in the analysis. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Clinical Benefit as Assessed by an IRC | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at Baseline were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment Failure | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | percentage of participants | NUMBER |
| SECONDARY | Time to Treatment Failure | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Symptom Progression | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Time to Symptom Progression | From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis. | Months | MEDIAN |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00829166/outcomes