Trial · NCT01227928
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months) | Intent-to-Treat (ITT) Population: all randomized participants who were not screen failures. Participants who were screen failures and randomized by mistake, but who did not receive study treatment, were not included. The treatment assignment in the ITT Population was based on the randomized treatment. The data cut off was October 12, 2012. | months | MEDIAN |
| SECONDARY | Overall Survival | From randomization until death due to any cause (average of 29.4 months) | ITT Population. Participants who were alive as of study completion were censored at the last contact date. The cut off for these data was January 10, 2014. | months | MEDIAN |
| SECONDARY | PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria | From randomization to the earliest date of disease progression per GCIG criteria or death due to any cause (average of 15.2 months) | ITT Population. The cut off for these data was October 12, 2012. | months | MEDIAN |
| SECONDARY | Number of Participants With Any Dose Reduction or Any Dose Interruption | From Week 1 until the end of the treatment period (up to Study Week 108) | All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. | participants | NUMBER |
| SECONDARY | Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) | From Week 1 until the end of the treatment period (up to Study Week 108) | All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014. | participants | NUMBER |
| SECONDARY | Number of Participants With Any On-therapy AE and Any AE Related to Study Treatment | From Week 1 until the end of the treatment period (up to Study Week 108) | All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014. | participants | NUMBER |
| SECONDARY | Number of Participants With Any Grade 3 or 4 AE | From Week 1 until the end of the treatment period (up to Study Week 108) | All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated On-therapy Grade 3-5 AEs | From Week 1 until the end of the treatment period (up to Study Week 108) | All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014. | participants | NUMBER |
| SECONDARY | Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment, Dose Interruption, and Dose Reduction | From Week 1 until the end of the treatment period (up to Study Week 108) | All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014. | participants | NUMBER |
| SECONDARY | Number of Participants With Any SAE, Any SAE Related to Study Treatment, and Any Fatal SAE | From Week 1 until the end of the treatment period (up to Study Week 108) | All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Worst-case On-therapy Blood Pressure Shifts From Baseline | From Week 1 until the end of the treatment period (up to Study Week 108) | All Treated Population. One participant on placebo did not report any blood pressure measurements post-Baseline. The cut off for these data was January 10, 2014. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Worst-case On-therapy Shift From Baseline in Bazett's Corrected QT Interval (QTc) | From Week 1 until the end of the treatment period (up to Study Week 108) | All Treated Population. Only those participants for which a post-Baseline ECG was conducted were analyzed. The cut off for these data was October 12, 2012. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Worst-case On-therapy Hematology Parameter Grade Shifts From Baseline Grade | From Week 1 until the end of the treatment period (up to Study Week 108) | All Treated Population. Data are presented for only those participants with laboratory values. The cut off for these data was October 12, 2012. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Worst-case On-therapy Chemistry Parameter Grade Shifts From Baseline Grade | From Week 1 until the end of the treatment period (up to Study Week 108) | All Treated Population. Data are presented for only those participants with laboratory values. The cut off for these data was October 12, 2012. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Worst-case Eastern Cooperative Oncology Group (ECOG) Performance Status Shifts From Baseline Grades of 0, 1, and 2 | From Week 1 until the end of the treatment period (up to Study Week 108) | All Treated Population. The cut off for these data was October 12, 2012. | participants | NUMBER |
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.
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GET https://conductscience.org/api/trials/v1/NCT01227928/outcomes