Trial · NCT03184870
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing Adverse Events (AEs) | From first dose up to 100 days post last dose, up to approximately 3 years | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Experiencing Serious Adverse Events (SAEs) | From first dose up to 100 days post last dose, up to approximately 3 years | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | From first dose up to 100 days post last dose, up to approximately 3 years | All treated participants who completed the DLT evaluation period | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | From first dose up to 100 days post last dose, up to approximately 3 years | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Died | From first dose up to 100 days post last dose, up to approximately 3 years | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Experiencing Laboratory Abnormalities | From first dose up to 100 days post last dose, up to approximately 3 years | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Vital Signs | From first dose to 100 days post last dose, up to approximately 3 years | All treated participants with vital sign measurements | mmHg | MEAN |
| PRIMARY | Number of Participants With Out-of-Range Electrocardiograms (ECG) | From baseline up to 100 days post last dose | All treated participants with out-of-range ECGs | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percent Change in Regulatory T Cells (Treg) in Tumor Samples | From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1) | All treated participants with immunohistochemistry data | Percent change in Treg | MEDIAN |
| PRIMARY | Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples | From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1) | All treated participants with immunohistochemistry data | Percent change in TAM | MEDIAN |
| PRIMARY | Objective Response Rate (ORR) | From first dose until disease progression, or the last response recorded (up to approximately 5 years) | All treated participants | Percent of participants | NUMBER |
| PRIMARY | Duration of Response (DoR) | From first dose up to date of disease progression or death, whichever occurs first (up to approximately 5 years) | All treated participants who achieved complete or partial response and were not censored | Weeks | MEDIAN |
| PRIMARY | Progression Free Survival (PFS) Rate at 24 Weeks | From first dose up to Week 24 | All treated participants who were assessed for progression free survival at Week 24 | Proportion of Participants | NUMBER |
| SECONDARY | Maximim Concentration (Cmax) | From first dose up to the prespecified timepoints, C0D1, C0D14, and C2D1 | Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data. | ng/mL | MEAN |
| SECONDARY | Time to Maximum Concentration (Tmax) | From first dose up to the prespecified timpoints, C0D1, C0D14, AND C2D1 | Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data. | Hours | MEDIAN |
| SECONDARY | Trough Observed Plasma Concentration (Ctrough) | From first dose up to prespecified timepoints, C0D1, C5D1, C0D1, C1D15, C5D1 | Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data. | ng/mL | MEAN |
| SECONDARY | Area Under Curve (AUC) 0-8 | From first dose up to prespecified timepoints- C0D1, C2D1 | Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data. | ug*h/mL | MEAN |
| SECONDARY | Area Under Curve (AUC) 0-24 | From first dose up to prespecified timepoints-C0D1, C2D1 | Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data. | ug*h/mL | MEAN |
| SECONDARY | Apparent Total Body Clearance (CLT/F) | From first dose up to prespecified timepoints-C0D1, C2D14 | Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data. | mL/min | MEAN |
| SECONDARY | Renal Clearance (CLR) | From first dose up to prespecified timepoints-C0D1, C0D14 | Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data. | mL/min | 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03184870/outcomes