Trial · NCT01313663
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 the first documented sign of investigator-assessed disease progression or death, whichever occurred first (average of 10 study weeks) | Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment regardless of whether or not treatment was administered | weeks | MEDIAN |
| SECONDARY | Overall Survival | From randomization until disease progression or death (up to Study Week 78) | The study size (20 participants) and follow up were not adequate to assess overall survival. Participants who had not died at the time of the cut-off for the analysis were to be censored at the date the particpant was last known to be alive. | ||
| SECONDARY | Number of Participants (Par.) With the Indicated Best Overall Response | From randomization until the time of the first documented evidence of a confirmed complete response (CR) or partial response (PR) (average of 10 weeks) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Any Non-serious On-therapy Adverse Event (AE: Occurring in >=5% Participants in Any Treatment Arm) and Serious Adverse Event (SAE) | From the time the first dose of study treatment was administered until 28 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (up to Study Week 55) | Safety Population: all participants who were randomized and took at least one dose of study medication. This population was based on the actual treatment received, if it differed from that to which the participant was randomized. | participants | NUMBER |
| SECONDARY | Time on Study Treatment (Pazopanib), as a Measure of Extent of Exposure | From the first day to the last day of treatment (average of 8 weeks) | Safety Population | months | MEAN |
| SECONDARY | Mean Daily Dose, as a Measure of Extent of Exposure | From the first day to the last day of treatment (average of 8 weeks) | Safety Population | milligrams | MEAN |
| SECONDARY | Mean Number of Pemetrexed Dosing Cycles, as a Measure of Extent of Exposure | From the time the first dose of study treatment was administered until discontinuation of the study or death (average of 16 weeks) | Safety Population | number of cycles | MEAN |
| SECONDARY | Average Dose of Pemetrexed for All Cycles, as a Measure of Extent of Exposure | From the time the first dose of study treatment was administered until discontinuation of the study or death (average of 16 weeks) | Safety Population | milligrams per meters squared (m^2) | MEAN |
| SECONDARY | Number of Participants With Any AE (Serious or Non-serious) Leading to Withdrawal From Study Treatment | From the time the first dose of study treatment was administered until withdrawal from study treatment (up to Study Week 55) | Safety Population | participants | NUMBER |
| SECONDARY | Number of Participants With Any On-therapy AE (Serious or Non-serious) Leading to Dose Reductions (DRs) or Interruptions/Delays in the Study | From the time the first dose of study treatment was administered until discontinuation of treatment (up to Study Week 55) | Safety Population | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Worst-case Change From Baseline in Blood Pressure | From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55) | Safety Population | participants | NUMBER |
| SECONDARY | Number of Participants With a Increase From Baseline in Bazett's QTc at the Indicated Time Points | Baseline; Week 6; Week 15; every 9 weeks in the first 6 months; every 12 weeks in the next 6 months; and, after 1 year, every 6 months (up to Study Week 55) | Safety Population | participants | NUMBER |
| SECONDARY | Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Laboratory Parameters | From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55) | Safety Population | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Grade Changes From Baseline Grade in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk. Phos.), and Total Bilirubin (TB) | From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55) | Safety Population | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Changes From Baseline Value in Lactate Dehydrogenase (LDH) | From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55) | Safety Population | 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/NCT01313663/outcomes