Trial · NCT04458909
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Baseline to the date of death or last follow-up. Maximum follow-up time was 2.3 years. | Randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Locoregional Failure | Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years. | Randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Distant Metastases | Randomization to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years. | Randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS) | Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years. | Randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete or Partial Response (Objective Response Rate) Through the End of Cycle 6 Determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Baseline through end of cycle 6 (each cycle is 21 days) | Randomized participants with scans at baseline and end of cycle 6 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Grade 3 or Higher Adverse Events (AEs) | Baseline to the date of last follow-up. Maximum follow-up time was 2.3 years. | Randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Baseline | Baseline | Randomized participants with any PRO-CTCAE data | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Severity Score ≥ 3 (or Present) at Cycle 6 | End of cycle 6 (each cycle is 21 days for the first six cycles) | Randomized participants with any PRO-CTCAE data | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | End of cycle 6 (each cycle is 21 days) | Randomized participants with cycle 6 data | score on a scale | MEAN |
| SECONDARY | Multidimensional Fatigue Inventory (MFI)-20 Total Score | End of cycle 6 (each cycle is 21 days) | Randomized participants with MFI data at cycle 6 | score on a scale | MEAN |
| SECONDARY | Progression-free Survival by Programmed Death Receptor Ligand-1 (PD-L1) Combined Positive Score (CPS) and Tumor Proportion Score (TPS) | Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years. | No assays were performed, and no data were collected for this outcome measure. | ||
| OTHER_PRE_SPECIFIED | Overall Survival by PD-L1 CPS and TPS | Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years. | |||
| OTHER_PRE_SPECIFIED | Change From Baseline to Cycle 6 in Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | Baseline and end of cycle 6 (each cycle is 21 days) | |||
| OTHER_PRE_SPECIFIED | Change From Baseline to Cycle 6 in Multidimensional Fatigue Inventory (MFI)-20 Total Score | Baseline and end of cycle 6 (each cycle is 21 days) | |||
| OTHER_PRE_SPECIFIED | Translational Research Studies | From randomization to last follow-up, assessed up to 8 years |
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/NCT04458909/outcomes