Trial · NCT03468426
Outcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Part 1 - Adverse Events (AEs) | Up to 1263 days. | All patients enrolled in part 1 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1 - Drug Related AEs | Up to 1263 days. | All patients enrolled in part 1 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1 - Drug Related AEs Leading to Dose Reduction or Discontinuation | Up to 1263 days. | All patients enrolled in part 1 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 2 - Adverse Events (AEs) | Up to 778 days. | All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 2 - Drug Related AEs | Up to 778 days. | All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 2 - Drug Related AEs Leading to Dose Reduction or Discontinuation | Up to 778 days. | All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 2 - Disease Control (DC) | Up to 778 days. | All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 2 - Duration of Objective Response (DoR) | Up to 84.4 weeks. | All patients with an objective response enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | weeks | MEDIAN |
| SECONDARY | Part 2 - Progression-free Survival (PFS) | Up to 778 days. | All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880. | weeks | MEDIAN |
| SECONDARY | Part 1 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the First Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle. | PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations. | microgram/milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 1 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the Fourth Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle. | PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations. | microgram/milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 1 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the First Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle. | PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations. | hours | GEOMETRIC_MEAN |
| SECONDARY | Part 1 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the Fourth Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle. | PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations. | hours | GEOMETRIC_MEAN |
| SECONDARY | Part 1 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle. | PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations. | hours*microgram/milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 1 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the Fourth Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle. | PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations. | hours*microgram/milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 2 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the First Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle. | PK analysis set (PKS) part 2: This patient set included all patients in part 2 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations. | microgram/milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 2 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the First Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle. | PK analysis set (PKS) part 2: This patient set included all patients in part 2 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations. | hours | GEOMETRIC_MEAN |
| SECONDARY | Part 2 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle. | PK analysis set (PKS) part 2: This patient set included all patients in part 2 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations. | hours*microgram/milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 1 - Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) After the First Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle. | PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations. | microgram/milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 1 - Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) After the Fourth Infusion Cycle | 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle. | PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations. | microgram/milliliter | GEOMETRIC_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.
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