Trial · NCT02302807
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled | Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1 | Up to approximately 25 months after first participant enrolled | Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received. | months | MEDIAN |
| SECONDARY | Unconfirmed Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1 | Up to approximately 25 months after first participant enrolled | DOR analyses was performed on the subset of patients who achieved an objective response. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Adverse Events (AEs) | Up to approximately 46 months after first participant enrolled | Safety analyses was performed on all randomized patients who received any amount of study treatment, with patients grouped according to whether any amount of atezolizumab was received including the case when atezolizumab was received in error. | percentage | NUMBER |
| SECONDARY | Percentage of Participants With Post-Baseline Anti-therapeutic Antibodies (ATA) to Atezolizumab | Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days) | ATA evaluable population is defined as patients who received atezolizumab treatment and had at least one post-treatment ATA result. | percentage of participants | NUMBER |
| SECONDARY | Minimum Observed Serum Atezolizumab Concentration (Cmin) | Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days) | The PK-evaluable population is defined as patients who received atezolizumab treatment and had at least one measureable PK concentration. | mcg/mL | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Unconfirmed Objective Response Rate (ORR) as Determined by the Investigator With Use of Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) | Up to approximately 25 months after first participant enrolled | ORR analyses was performed on all randomized patients who had measureable disease at baseline | Percentage of participants | NUMBER |
| SECONDARY | Maximum Observed Serum Atezolizumab Concentration (Cmax) | 30 minutes post dose on Day 1 of Cycles 1 | The PK-evaluable population is defined as patients who received atezolizumab treatment and had at least one measureable PK concentration. | mcg/mL | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Global Health Status Scale | Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days) | All randomized patients with non-missing baseline assessment and at least one non-missing post-baseline assessment. | units of a scale | MEAN |
| SECONDARY | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Physical Functioning Scale | Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days) | All randomized patients with non-missing baseline assessment and at least one non-missing post-baseline assessment. | units of a scale | MEAN |
| SECONDARY | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Fatigue Symptom Scale | Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days) | All randomized patients with non-missing baseline assessment and at least one non-missing post-baseline assessment. | units of a scale | MEAN |
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/NCT02302807/outcomes