Trial · NCT00866697
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Investigator-assessed Progression-free Survival (PFS) | From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo) | Intent-to-Treat (ITT) Population: all randomized participants | months | MEDIAN |
| SECONDARY | Overall Survival - Median | From the date of randomization until the date of death due to any cause up to approximately 25 months | Intent-to-Treat (ITT) Population: all randomized participants | months | MEDIAN |
| SECONDARY | Overall Survival: Number of Participants Experiencing Death | From the date of randomization until the date of death due to any cause up to approximately 25 months | Intent-to-Treat (ITT) Population: all randomized participants | participants | NUMBER |
| SECONDARY | Progression-free Survival Per Gynecologic Cancer Intergroup (GCIG) Criteria | From the date of randomization until the date of progression per GCIG criteria or death due to any cause (median time of follow-up was 16.8 months for pazopanib and 11.9 months for placebo) | Intent-to-Treat (ITT) Population: all randomized participants.~For participants who did not progress or die, progression-free survival was censored at the time of the last adequate disease assessment. | months | MEDIAN |
| SECONDARY | 3-year Progression-free Survival | Up to 3 years after randomization | Intent-to-Treat (ITT) Population: all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25 | Baseline; Week 13; Months 7, 10, 13, 16, and 25 | ITT Population. Only those participants available at the specified time points were analyzed. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in QLQ-OV-28 Module Attitude to Disease/Treatment Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25 | Baseline; Week 13; Months 7, 10, 13, 16, and 25 | ITT Population. Only those participants available at the specified time points were analyzed. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in QLQ-OV-28 Module Body Image Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25 | Baseline; Week 13; Months 7, 10, 13, 16, and 25 | ITT Population. Only those participants available at the specified time points were analyzed. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in QLQ-OV-28 Module Peripheral Neuropathy (PN) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25 | Baseline; Week 13; Months 7, 10, 13, 16, and 25 | ITT Population. Only those participants available at the specified time points were analyzed. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in QLQ-OV-28 Module Abdominal (AB)/Gastrointestinal (GI) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25 | Baseline; Week 13; Months 7, 10, 13, 16, and 25 | ITT Population. Only those participants available at the specified time points were analyzed. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in QLQ-OV-28 Module Hormonal/Menopausal Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25 | Baseline; Week 13; Months 7, 10, 13, 16, and 25 | ITT Population. Only those participants available at the specified time points were analyzed. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in QLQ-OV-28 Module Sexuality Functional on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25 | Baseline; Week 13; Months 7, 10, 13, 16, and 25 | Data were not analyzed due to low compliance (\<50% at Baseline). | ||
| SECONDARY | Change From Baseline in QLQ-OV-28 Module Other Chemotherapy Side Effects (SE) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25 | Baseline; Week 13; Months 7, 10, 13, 16, and 25 | Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (\<50% at Baseline). | ||
| SECONDARY | Change From Baseline in the EuroQOL EQ-5D (Five Dimensions) Thermometer Score at Week 13 and Months 7, 10, 13, 16, and 25 | Baseline; Week 13; Months 7, 10, 13, 16, and 25 | Intent-to-Treat (ITT) Population: all randomized participants.~Only those participants available at the specified time points were analyzed. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the EQ-5D (Five Dimensions) Utility Score at Week 13 and Months 7, 10, 13, 16, and 25 | Baseline; Week 13; Months 7, 10, 13, 16, and 25 | Intent-to-Treat (ITT) Population: all randomized participants.~Only those participants available at the specified time points were analyzed. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With the Indicated Grade 2, 3, and 4 On-therapy Adverse Events Occurring in >=10% of Participants in Either Treatment Arm | From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo) | All Treated Population | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated On-therapy Hematology Grade Shifts From Baseline Grade | From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo) | All Treated Population. Only those participants contributing toxicity data were analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated On-therapy Chemistry Grade Shifts From Baseline Grade | From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo) | All Treated Population. Only those participants contributing toxicity data were analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Treatment-emergent Thyroid-stimulating Hormone (TSH) Elevations Above 5 Million Units Per Liter (MU/L) | From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo) | All Treated Population. Only those participants with any TSH above 5 MU/L were analyzed. | participants | NUMBER |
| POST_HOC | All Collected Deaths | on-treatment: up to 27 months; post-treatment: up to 96 months (8 years). | Treated set.~One randomized patient in each treatment arm was excluded from the All Treated population because they did not receive treatment. The pazopanib group included 6 patients who were randomized to placebo but took at least one dose of pazopanib.~Four patients (one in placebo, three in pazopanib) had missing death dates and therefore were treated as censored at the last contact date. | 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.
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