Trial · NCT03052608
Outcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) Assessment | From time of Study Start up to 33 months | The full analysis (FA) population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From time of Study Start up to 33 months | The FA population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) Based on Investigator's Assessment | From time of Study Start up to 33 months | The FA population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on BICR Assessment | From time of Study Start up to 33 months | The FA population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on Investigator's Assessment | From time of Study Start up to 33 months | The FA population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Intracranial Objective Response Rate (IC-ORR) - Percentage of Participants With Intracranial Objective Response (IC-OR) Based on BICR Assessment | From time of Study Start up to 33 months | The subset of the FA population with at least 1 baseline intracranial lesion (based on BICR intracranial assessment). | Percentage of participants | NUMBER |
| SECONDARY | Intracranial Time to Progression (IC-TTP) Based on BICR Assessment | From time of Study Start up to 33 months | The FA population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization. | Months | MEDIAN |
| SECONDARY | Duration of Response (DR) Based on BICR Assessment | From time of Study Start up to 33 months | Participants with a confirmed objective response (complete response or partial response) per RECIST version 1.1 in the FA population. | Months | MEDIAN |
| SECONDARY | Intracranial Duration of Response (IC-DR) Based on BICR Assessment | From time of Study Start up to 33 months | Participants with brain metastases at baseline and confirmed intracranial complete response or partial response in the FA population. | Months | MEDIAN |
| SECONDARY | Time to Tumor Response (TTR) Based on BICR Assessment | From time of Study Start up to 33 months | Participants with confirmed complete response or partial response in the FA population. | Months | MEDIAN |
| SECONDARY | Intracranial Time to Tumor Response (IC-TTR) Based on BICR Assessment | From time of Study Start up to 33 months | Participants with brain metastases at baseline and confirmed intracranial complete response or partial response in the FA population. | Months | MEDIAN |
| SECONDARY | PFS2 Based on Investigator's Assessment | From time of Study Start up to 45 months | |||
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (AEs; All-Causality and Treatment-Related) | From time of Study Start up to 33 months | The safety analysis population included all participants who received at least 1 dose of study drug. Participants were classified according to the treatment assigned at randomization unless the incorrect treatment(s) were received throughout the dosing period, in which case participants were classified according to the first study treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Changes in Hematology Laboratory Parameters From Baseline Maximum NCI-CTCAE Grade Lower Than 3 to Postbaseline Maximum Grade 3 or Grade 4 | From Baseline up to 33 months | Participants in the safety analysis population who had at least one on-study assessment for the parameter of interest. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Changes in Chemistry Laboratory Parameters From Baseline Maximum NCI-CTCAE Grade Lower Than 3 to Postbaseline Maximum Grade 3 or Grade 4 | From Baseline up to 33 months | Participants in the safety analysis population who had at least one on-study assessment for the parameter of interest. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Changes in Lipid Laboratory Parameters From Baseline Maximum NCI-CTCAE Grade Lower Than 3 to Postbaseline Maximum Grade 3 or Grade 4 | From Baseline up to 33 months | Participants in the safety analysis population who had at least one on-study assessment for the parameter of interest. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participant With Vital Signs and Body Weight Data Meeting Pre-defined Criteria | From Baseline up to 33 months | Number of Participants Analyzed included all participants in the safety analysis population. Number Analyzed included all participants in the safety analysis population with evaluable data against the pre-defined criteria. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participant With Maximum Increase From Baseline in Electrocardiogram (ECG) Data Meeting Pre-defined Criteria | From Baseline up to 33 months | Number of Participants Analyzed included all participants in the safety analysis population. Number Analyzed included all participants in the safety analysis population with evaluable data against the pre-defined criteria. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Maximum Decrease From Baseline Greater Than or Equal to 20 Points in Left Ventricular Ejection Fraction (LVEF) Percentage | From Baseline up to 33 months | All participants in the safety analysis population who had at least one on-study assessment for the parameter of interest. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Total Scores of Beck Depression Inventory (BDI)-II (Mood Assessment) Across Time | Baseline, Cycle 2 Day 1 (C2D1), C3D1, C4D1, C5D1, C6D1, C8D1, C10D1, C12D1, C14D1, C16D1, C18D1, C20D1, C22D1, C24D1, C26D1, C28D1, C30D1, C32D1, C34D1, C36D1, C38D1 and End of Treatment | Number of Participants Analyzed included all participants in the safety analysis population within each treatment group. Number Analyzed included all participants with at least a baseline and postbaseline assessment at the visit. | Units on a scale | 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.
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GET https://conductscience.org/api/trials/v1/NCT03052608/outcomes