Trial · NCT02723955
Outcomes80
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 80
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Up to approximately 367 weeks | All Treated population included all participants who received at least one dose of feladilimab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1A: Number of Participants With Dose Limiting Toxicity (DLT) | Up to 28 days | DLT Evaluable Population included All Treated Population in the dose escalation phase or PK/PD cohorts, who completed the 28-day DLT observation period or experienced a DLT during the determinative period (28 days). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1A: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Baseline (Day 1) and up to approximately 367 weeks | All Treated Population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to approximately 367 weeks | All Treated Population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1A: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Baseline (Day 1) and up to approximately 367 weeks | All Treated Population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to approximately 367 weeks | All Treated Population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1A: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Up to approximately 367 weeks | All treated population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1A: Number of Participants With Dose Modifications of Feladilimab | Up to approximately 367 weeks | All treated population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Up to approximately 367 weeks | All Treated population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2A: Number of Participants With Dose Limiting Toxicity (DLT) | Up to 28 days | DLT Evaluable Population. As pre-specified in the protocol, only specified treatment arms were planned and hence there are 0 participants analyzed for rest of the arms. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2A: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Baseline (Day 1) and up to approximately 367 weeks | All Treated Population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to approximately 367 weeks | All Treated Population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2A: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Baseline (Day 1) and up to approximately 367 weeks | All Treated Population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to approximately 367 weeks | All Treated Population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2A: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline | Up to approximately 367 weeks | All treated population. Only those participants with data available at specified categories have been analyzed | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2A: Number of Participants With Dose Modifications of Feladilimab | Up to approximately 367 weeks | All Treated population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1B: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Up to approximately 367 weeks | All Treated population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1B: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | Baseline (Day 1) and up to approximately 367 weeks | All Treated Population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1B: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to approximately 367 weeks | All Treated Population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1B: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Baseline (Day 1) and up to approximately 367 weeks | All Treated Population. Only those participants with data available at specified categories have been analyzed. | Participants | COUNT_OF_PARTICIPANTS |
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.
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