Trial · NCT03130959
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs) | up to 6 weeks post-dosing | Safety Lead-in participants: In Module A, the first 6 DLT-evaluable participants in Cohort 1 and the first 10 DLT-evaluable participants in Cohorts 2-5; in Module B, the first 10 DLT-evaluable participants. | Number of participants | NUMBER |
| PRIMARY | Number of Safety Lead-In Participants With Serious Adverse Events (SAEs) | up to 6 weeks post-dosing | Safety Lead-in participants: In Module A, the first 6 DLT-evaluable participants in Cohort 1 and the first 10 DLT-evaluable participants in Cohorts 2-5; in Module B, the first 10 DLT-evaluable participants. | Number of participants | NUMBER |
| PRIMARY | Number of Safety Lead-In Participants With Adverse Events (AEs) Leading to Discontinuation | From first dose to 30 days post-last dose (up to approximately 6 weeks) | Safety Lead-in participants: In Module A, the first 6 DLT-evaluable participants in Cohort 1 and the first 10 DLT-evaluable participants in Cohorts 2-5; in Module B, the first 10 DLT-evaluable participants. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Survival (OS), Cohort 1 Only | up to approximately 42 months | All treated participants | months | MEDIAN |
| PRIMARY | Progression-Free Survival (PFS), Cohorts 2-4 | up to approximately 42 months | All treated participants | months | MEDIAN |
| PRIMARY | Progression-Free Survival (PFS), Cohort 5 Only | up to approximately 42 months | All treated participants | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS), Cohort 1 Only | From first dose to the date of the first documented tumor progression or death due to any cause (up to approximately 55 months) | All treated participants in Cohort 1 | Months | MEDIAN |
| SECONDARY | Overall Survival at 12 Months (OS12), Cohorts 1-4 | From first dose to up to 12 months after first dose | All treated participants in Cohorts 1-4 | Percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival at 6 Months (PFS6), Cohorts 2-5 | From first dose to up to 6 months after first dose | All treated participants in Cohorts 2-5 | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS), Cohorts 2-5 | From first dose to the date of death (up to approximately 55 months) | All treated participants in Cohorts 2-5 | Months | MEDIAN |
| SECONDARY | Number of Treated Participants With Adverse Events (AEs) | From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Treated Participants With Serious Adverse Events (SAEs) | From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Treated Participants With Drug-Related Adverse Events | From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Treated Participants With Adverse Events Leading to Discontinuation | From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Treated Participant Deaths | From first dose to the date of death (up to approximately 55 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Treated Participant With Laboratory Abnormalities - Liver | From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Treated Participant With Laboratory Abnormalities - Thyroid | From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months) | All treated participants with at least one on-treatment TSH measurement | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Overall Survival (OS), Cohort 1 Only - Extended Collection | From first dose to the date of death (up to approximately 55 months) | All treated participants in Cohort 1 | Months | MEDIAN |
| POST_HOC | Progression-Free Survival (PFS), Cohorts 2-4 - Extended Collection | From first dose to the date of the first documented tumor progression or death due to any cause (up to approximately 55 months) | All treated participants in Cohorts 2-4 | Months | MEDIAN |
| POST_HOC | Progression-Free Survival (PFS), Cohort 5 Only - Extended Collection | From first dose to the date of the first documented tumor progression or death due to any cause (up to approximately 55 months) | All treated participants in Cohort 5 | Months | MEDIAN |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03130959/outcomes