Trial · NCT00689221
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 | Overall Survival (OS) Time | Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012) | ITT population included all the participants who were randomized to study treatment. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Time - Investigator and Independent Read | Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012) | ITT population included all the participants who were randomized to study treatment. | Months | MEDIAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) | Day 1 of Week -1 | Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1. | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Time to Maximum Plasma Concentration (Tmax) | Day 1 of Week -1 | Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1. | hours | MEAN |
| SECONDARY | Area Under the Plasma Concentration Curve From Time 0 to 6 Hours (AUC [0-6]) After Dose | Day 1 of Week -1 | Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | hour*ng/mL | MEAN |
| SECONDARY | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Sub-scale Scores | Up to 50 months | ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category. | units on a scale | MEAN |
| SECONDARY | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Brain Module (EORTC QLQ-BN20) Sub-scale Scores | Up to 50 months | ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category. | units on a scale | MEAN |
| SECONDARY | EuroQol 5-Dimensions (EQ-5D) Questionnaire Index | Up to 50 months | ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Change From Baseline in Work Status at End of Study | Baseline, End of study (up to cut-off date, [19 Nov 2012]) | Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period. | participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment Related AEs of Grade 3 or 4 | Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012) | Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period. | Participants | NUMBER |
| SECONDARY | Number of Participants With AEs Belonging to Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) Thromboembolic Events and Hemorrhage With NCI-CTC Toxicity Grade 3 or 4 | Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012) | Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period. | Participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) and Lab Parameters | Up to 50 months | Any clinically significant abnormal ECG and lab finding was planned to be reported as AE only so they have been captured in the below mentioned adverse event section. |
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/NCT00689221/outcomes