Trial · NCT00075218
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase | Day 28 of each 6-week cycle : duration of double-blind treatment phase | Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors). |
| Primary | Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study | Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV) | Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors). |
| Secondary | Progression Free Survival (PFS) | Day 28 of each cycle : duration of double-blind treatment phase | Time from randomization to first documentation of objective tumor progression or to death due to any cause (on treatment or within 28 days of last dose). |
| Secondary | Overall Survival Status of Subjects | clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug | Number of subjects alive at end of study. |
| Secondary | Overall Survival | clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug | Time from date of randomization to date of death due to any cause. |
| Secondary | Overall Survival Based on the Rank Preserving Structural Failure Time Method | clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug | time from date of randomization to date of death due to any cause (rank preserving structural failure time method). |
| Secondary | Best Overall Tumor Response During Double-blind Treatment Phase | Day 28 of each cycle : duration of double-blind treatment phase | Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST). |
| Secondary | Confirmed Objective Response (CR or PR) in Subjects | Day 28 of each cycle : duration of double-blind treatment phase | Overall confirmed objective response = confirmed Complete Response (CR) OR confirmed Partial Response (PR) according to RECIST. Confirmed responses were those that persisted on repeat imaging study ≥ 4 weeks after initial documentation of response. |
| Secondary | Time to Tumor Response (TTR) | Day 28 of each cycle : duration of double-blind treatment phase | Time from date of randomization to first documentation of objective tumor response that was subsequently confirmed. TTR was only calculated for the subgroup of subjects with a confirmed objective tumor response. |
| Secondary | Duration of Performance Status Maintenance | Day 28 of each cycle : duration of double-blind treatment phase | Time from randomization until the last time the performance status was no worse than at baseline or to death due to cancer in the absence of previous documentation of performance status worsening. |
| Secondary | Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI) | Day 1 & 28 of each cycle : duration of double-blind treatment phase | 25th Quartile: Time to Progression. Progression: a) No change (NC) in MPQ-PPI score (0=no pain to 5=excruciating pain) with increase total analgesic use \>= 50% over baseline OR b) Increase score \>= 1 point with either NC in total analgesic use or increase total analgesic use \>= 50% over baseline. (50th Quartile not achieved.) |
| Secondary | Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI) | Day 1 & 28 of each cycle : duration of double-blind treatment phase | MPQ-PPI: 0=no pain to 5= excruciating pain. Pain Relief Response= 1) Decrease by \>= 1 points in MPQ-PPI score with either Decrease or No Change in total analgesic use \>= 50% over baseline OR 2) No change in MPQ-PPI score with Decrease total analgesic use \>= 50% over baseline. |
| Secondary | Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS) | Day 1 & 28 of each cycle : duration of double-blind treatment phase | Change: median score at observation minus median score at baseline. EQ-VAS score on the self-rated "thermometer," indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. |
| Secondary | Change From Baseline in EQ-5D Health State Profile Index | Day 1 & 28 of each cycle : duration of double-blind treatment phase | Change: median index score at observation minus median index score at baseline. EQ-5D is a generic instrument that describes health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where where 0.0 = death and 1.0 = perfect health. |
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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