Trial · NCT00967330
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months | 6 months | Intent-to-treat (ITT) population included participants randomized for whom it cannot be ruled out, that they took study medication at least once and where primary variable was measured at least once under study medication. Data were analyzed according to the treatment randomized (as randomized). | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | From baseline to the end of the study (up to 4.5 years) | ITT population. Data were analyzed according to the treatment randomized (as randomized). | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From baseline until death (up to 4.5 years) | ITT population. Data were analyzed according to the treatment randomized (as randomized). | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Discontinued | From baseline until death (up to 4.5 years) | ITT population | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With A Best Overall Response (BOR) of Complete Response (CR) and With A BOR of CR or Partial Response (PR) | 4 week after radiotherapy (RT) (up to Week 4), >4 Week after RT (up to Week 8) and Month 6 | ITT population. Data were analyzed according to the treatment randomized (as randomized). Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable of specified time-point. | participants | NUMBER |
| SECONDARY | Percentage of Participants With Response on FLAIR Imaging | At screening, Baseline, Month 6 and Therapy Discontinuation (Up to 4.5 years) | ITT population. Here, n = participants with at least 1 assessment during specified time-point. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ - C30) at Baseline, Post-Baseline (up to Month 30) | Baseline, Post-Baseline (up to Month 30) | ITT population. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for EORTC QLQ Brain Neoplasm 20 (BN20) at Baseline, Post-Baseline (up to Month 30) | Baseline, Post-Baseline (up to Month 30) | ITT population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for Mini-Mental Status Examination (MMSE) at Baseline, Post-Baseline (up to Month 30) | Baseline, Post-Baseline (up to Month 30) | ITT population. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for Karnofsky Performance Status (KPS) Score at Baseline, Post-Baseline (up to Month 30) | Baseline, Post-Baseline (up to Month 30) | ITT population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Received Corticosteroid for Glioblastoma | From baseline to Month 6 | The safety population (SAF) was defined to include all participants who received at least 1 dose of study medication. Data were analyzed according to the treatment actually received (as treated). | percentage of participants | NUMBER |
| SECONDARY | Time to Treatment Failure | From baseline until end of study (up to 4.5 years) | Data for this outcome measure were not collected as this outcome was removed as per changes in planned analysis. | years | 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/NCT00967330/outcomes