Trial · NCT03498716
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Invasive Disease-Free Survival (iDFS) | From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years) | ITT population included all randomized participants, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Invasive Disease-Free Survival (iDFS) in the Subpopulation With Programmed Death-ligand 1 (PD-L1) Selected Tumor Status (IC1/2/3) | From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years) | PD-L1-positive subpopulation included participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization. ITT population included all randomized participants, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Invasive Disease-Free Survival (iDFS) in the Node Positive Subpopulation | From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years) | Node positive subpopulation included all participants in the ITT population whose lymph node (LN) status was positive at the time of randomization. ITT population included all randomized participants, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization up to death from any cause (up to 5 years) | ITT population included all randomized participants, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Invasive Disease-Free Survival (iDFS) Including Second Primary Non-Breast Invasive Cancer | From randomization up to death from any cause (up to 5 years) | ITT population included all randomized participants, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Recurrence-Free Interval (RFI) | From randomization up to 5 years | ITT population included all randomized participants, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Distant Recurrence-Free Interval (DRFI) | From randomization up to 5 years | ITT population included all randomized participants, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Disease-Free Survival (DFS) | From randomization up to first disease recurrence or death from any cause (up to 5 years) | ITT population included all randomized participants, whether or not the assigned study treatment was received. | months | MEDIAN |
| SECONDARY | Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Patient-reported Function (Role Functioning [Q6, Q7]) | Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles | Patient-reported outcome (PRO)-evaluable populations included participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the EORTC QLQC30. ITT population included all randomized participants, whether or not the assigned study treatment was received. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified time point. | score on scale | MEAN |
| SECONDARY | Change From Baseline in EORTC QLQ-C30 Patient-reported Function (Physical Functioning [Q1-Q5]) | Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles | PRO-evaluable populations included participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the EORTC QLQC30. ITT population included all randomized participants, whether or not the assigned study treatment was received. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified time point. | score on scale | MEAN |
| SECONDARY | Change From Baseline in EORTC QLQ-C30 Global Health Status (GHS) [Q29] and Health-Related Quality of Life (HRQoL) [Q30] Combined Score | Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately 351 days); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles | PRO-evaluable populations included participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the EORTC QLQC30. ITT population included all randomized participants, whether or not the assigned study treatment was received. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified time point. | score on scale | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AE) | Up to 5 years | Safety Evaluable Population included all participants who received any amount of any study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serum Concentration of Atezolizumab | Postdose Day 1 of Cycle 1; Predose Day 1 of Cycles 2, 3, and 4; Predose Cycles 6, 10, and 14; Predose Day 2 of Cycle 16; Cycles 1-5= 28-day cycles; Cycles 6-16: 21-day cycles | Pharmacokinetic (PK)-evaluable population included all participants who received any dose of study medication and who have at least one evaluable postbaseline PK sample. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified time point. | microgram per milliliter (µg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | Up to 5 years | Safety Evaluable Population included all participants who received any amount of any study drug. Number analyzed at baseline and postbaseline are unique number of participants out of all the assessed participants who may have been ADA positive at that timepoint. Different participants may have contributed data for baseline and postbaseline. | percentage of 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
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GET https://conductscience.org/api/trials/v1/NCT03498716/outcomes