Trial · NCT03011372
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Complete Response (CR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population: all enrolled participants with an FGFR1 rearrangement and who received at least 1 dose of study drug. For this report, the full EEP included both previously treated and treatment-naive participants. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants Who Achieved CR as Determined by Central Review Committee (CRC) Assessment | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. CMR=complete metabolic response; PMR=partial metabolic response. Response criteria by investigator assessment were the same for chronic phase (CP) and blast phase (BP). | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants Who Achieved a Best Overall Response of CR or PR as Determined by CRC Assessment | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a Complete Cytogenetic Response (CCyR) as Assessed by Local Analysis and Investigator Evaluation | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants Who Achieved a CCyR as Assessed by CRC Assessment | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a Partial Cytogenetic Response (PCyR) as Assessed by Local Analysis and Investigator Evaluation | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a PCyR as Assessed by CRC Assessment | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Confidence intervals were calculated based on the exact method for binomial distribution. | percentage of participants | NUMBER |
| SECONDARY | Duration of Complete Response | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Only participants with a complete response were analyzed. Confidence intervals were calculated using the Brookmeyer and Crowley's method. | months | MEDIAN |
| SECONDARY | Duration of Response | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Only participants with complete response or partial response were analyzed. Confidence intervals were calculated based on the exact method for binomial distribution. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. The confidence interval was calculated using the Brookmeyer and Crowley's method. Participants who were still alive without experiencing disease progression at the time of analysis were censored at the date of the last response assessment before the cutoff date. Participants who started a new cancer therapy before disease progression were censored at the date of last response assessment before new cancer therapy start. | months | MEDIAN |
| SECONDARY | Overall Survival | up to 2513 days (120 21-day treatment cycles) | Full Efficacy-Evaluable Population. Confidence intervals were calculated using the Brookmeyer and Crowley's method. Participants without death observed at the time of the analysis were censored at the last date known to be alive. | months | MEDIAN |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to 2543 days | Safety Population: all enrolled participants who received at least 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any ≥Grade 3 TEAE | up to 2543 days | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
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/NCT03011372/outcomes