Trial · NCT02610140
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), [95% CI] | From randomization till approximately 117 PFS events observed, up to approx. 30 months (data cut-off: 31-May-2017) | Progression-free survival (PFS), defined as time from randomization until disease progression according to mRECIST (Modified Response Evaluation Criteria in Solid Tumors) for Malignant pleural mesothelioma (MPM) per blinded central radiology review, or death. Only descriptive analysis of OS was repeated in the follow-up period. |
| Secondary | Overall Survival (OS), [95% CI] | Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause; one-sided log-rank test stratified by time to progression (TTP) on first line treatment. | Overall survival (OS) was defined as time from randomization until death from any cause. |
| Secondary | Objective Response Rate (ORR) | up to approx. 30 months (data cut-off: 31-May-2017) - Time from randomization until death from any cause. | A patient is a responder if the patient has a confirmed best tumor response on-study of CR (Complete response) or PR (Partial response), as determined by the central radiological reviewer per mRECIST criteria. ORR in each treatment arm was defined as the number of responders divided by the number of randomized patients. A responder was a patient who had a confirmed best tumor response on-study of CR or PR, as determined by the central radiological reviewer per mRECIST criteria. |
| Secondary | Disease Control Rate (DCR) | Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause. | A patient has disease control if the patient has a best tumor response on-study of CR, PR, or SD (Stable disease). DCR was defined as a percentage of patients achieving CR, PR, or SD per mRECIST criteria, as determined by the central radiological reviewer. DCR was calculated in each treatment arm as the number of patients with disease control (a best tumor response on-study of CR, PR, or SD) divided by the number of randomized patients. |
| Secondary | Duration of Response (DOR) | Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause. | DOR was defined in responders as the time from central documentation of tumor response date of first response in the confirmation sequence) to the earlier of disease progression as determined by the central radiological reviewer, or death without centrally documented progression. A responder was a patient who had a confirmed best tumor response on-study of CR or PR, as determined by the central radiological reviewer per mRECIST criteria. |
| Secondary | Durable Response Rate (DRR) | Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause. | A durable responder was a responder (i.e. confirmed best tumor response on study of CR or PR) with duration of response of 180 days or more. |
| Secondary | Percentage of Participants With Confirmed Improvement of Symptoms Characteristic of Mesothelioma | up to approx. 30 months (data cut-off: 31-May-2017) | Improvement rate of symptoms characteristic of mesothelioma was defined as the number of patients with confirmed improvement of symptoms characteristic of mesothelioma (based on the MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma, MDASI-MPM), divided by the number of patients evaluable for improvement of symptoms characteristic of mesothelioma. |
| Secondary | Time to Worsening of Symptoms Characteristic of Mesothelioma | up to approx. 30 months (data cut-off: 31-May-2017) | Time to worsening of symptoms characteristic of mesothelioma (TTWS) was defined in patients evaluable for assessing worsening of symptoms, as the time from randomization until the first worsening of symptoms characteristic of mesothelioma. Patients who died, were lost to follow-up, or ended (MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma) MDASI-MPM assessments without confirmed worsening of symptoms were censored at the date of their last MDASI-MPM assessment with a non-missing (Composite Symptom Score) CSS. |
| Secondary | Time to Worsening of Pain | up to approx. 30 months (data cut-off: 31-May-2017) | Time to worsening of pain (TTWP) was defined in patients evaluable for assessing worsening of pain, as time from randomization until the first worsening of pain. Patients who died, were lost to follow-up, or ended (MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma) MDASI-MPM assessments without confirmed worsening of pain were censored at the date of their last MDASI-MPM assessment with a non-missing pain score. |
| Secondary | Percentage of Participants With Confirmed Improvement of Pain | Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause. | Improvement rate of pain was defined as the number of patients with confirmed improvement of pain (based on the "pain at its worst" item of MDASI-MPM), divided by the number of patients evaluable for improvement of pain. |
| Secondary | Percentage of Participant With Treatment-emergent Adverse Events (TEAEs) | Up to approx. 55 months (data cut-off: 02-Jul-2019) - Time from randomization until 30 days after last treatment (general AEs), or further until death from any cause (selected AEs). | TEAEs were defined as all AEs starting or worsening within the treatment period. |
| Secondary | Number of Deaths | Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause. | TEAE(s) associated with a fatal outcome (CTCAE Grade 5) at the time of the data cut-off 06-Apr-2018. |
| Secondary | Overall Survival (OS) - Addendum | Up to approx. 55 month (data cut-off: 02-JUL-2019) - Time from randomization until death from any cause | Overall survival (OS) was defined as time from randomization until death from any cause; Only descriptive analyses of OS were repeated in with the data as of the 02 JUL 2019. |
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
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GET https://conductscience.org/api/trials/v1/NCT02610140/registered