Trial · NCT03869892
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Up to 24 months | Time elapsed between the randomization and the date of radiological tumour progression (according to RECIST 1.1) or death from any cause. |
| Secondary | Overall Survival (OS) | Up to 8 years | Time elapsed between the date of randomization and the date of death due to any cause. |
| Secondary | Overall response rate (ORR) | Up to 8 years | The proportion of patients with objective evidence of complete response (CR) or partial response (PR) according to RECIST 1.1 criteria and using investigator's tumour assessment. |
| Secondary | Disease control rate (DCR) | Up to 8 years | The proportion of patients with objective evidence of CR or PR or stable disease (SD) according to RECIST 1.1 criteria and using investigator's tumour assessment. |
| Secondary | Duration of response (DoR) | Up to 8 years | The time from the first documentation of response (CR or PR) to the first documentation of objective tumour progression or death due to any cause, whichever occurs first. |
| Secondary | Time to treatment failure (TTF) | Up to 8 years | The time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death. |
| Secondary | Incidence of Adverse Events (AEs) | Up to 8 years | |
| Secondary | Number of clinically significant changes to hematology, biochemistry, coagulation and urinalysis tests | Up to 8 years | |
| Secondary | Changes in ECOG performance status | Up to 8 years | |
| Secondary | Number of clinically significant changes to blood pressure, heart rate, body temperature and body weight | Up to 8 years | |
| Secondary | Number of clinically significant changes to 12-leads ECG parameters | Up to 8 years | |
| Secondary | Quality of life as assessed by EORTC QLQ-C30 | Up to 8 years | European organization for research and treatment of cancer (EORTC) Quality of Life Questionnaire - Core Questionnaire (QLQ-C30) scores range from 0-100 and assess functional and symptom scores. For functional scores, a higher score represents an increase in functioning. For symptom scores, a higher score represents an increase in symptoms. |
| Secondary | Quality of life as assessed by EQ-5D-5L | Up to 8 years | The 5-level EQ-5D version questionnaire scores range from 5 to 25 with a higher score representing a worse health status. |
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/NCT03869892/registered