TriangleNCT03962543 · OUTCOME
Confirmed Objective Response Rate at the End of the Treatment Phase.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 24 months
What was measured
Response will be determined by a blinded centralized review of volumetric MRI. The confirmed objective response rate (complete or partial response) by the end of Treatment Phase (i.e., Cycle 24) is defined as the proportion of participants who have a confirmed ≥ 20% reduction in target tumor volume as compared to baseline as assessed by a BICR, and the response needs to be confirmed by BICR in a consecutive tumor assessment within 2 - 6 months. Partial response is defined as a ≥ 20% reduction in target tumor volume from baseline. Complete response is defined as the complete resolution of the target tumor.
Analysis population: The Full Analysis Set is defined as patients who received at least one dose of Mirdametinib.
Groups in this outcome
Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901)
Patients aged 2 to 17 years old at the time of informed consent. Mirdametinib (PD-0325901) capsule or dispersible tablet 2 mg/m\^2 (maximum dose of 4 mg) by mouth twice daily
Treatment Phase - Adult Cohort Mirdametinib (PD-0325901)
Patients aged 18 and above at the time of informed consent. Mirdametinib (PD-0325901) capsule or dispersible tablet 2 mg/m\^2 (maximum dose of 4 mg) by mouth twice daily
| Group | Source count |
|---|---|
| Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) | 56 |
| Treatment Phase - Adult Cohort Mirdametinib (PD-0325901) | 58 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) | 51.8 | Not reported | 38.0 | 65.3 | Not reported |
| Treatment Phase - Adult Cohort Mirdametinib (PD-0325901) | 41.4 | Not reported | 28.6 | 55.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 38.0
- upper Limit
- 65.3
- value
- 51.8
- group Id
- OG001
- lower Limit
- 28.6
- upper Limit
- 55.1
- value
- 41.4
- denoms
- counts
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 58
- units
- Participants
- description
- Response will be determined by a blinded centralized review of volumetric MRI. The confirmed objective response rate (complete or partial response) by the end of Treatment Phase (i.e., Cycle 24) is defined as the proportion of participants who have a confirmed ≥ 20% reduction in target tumor volume as compared to baseline as assessed by a BICR, and the response needs to be confirmed by BICR in a consecutive tumor assessment within 2 - 6 months. Partial response is defined as a ≥ 20% reduction in target tumor volume from baseline. Complete response is defined as the complete resolution of the target tumor.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients aged 2 to 17 years old at the time of informed consent. Mirdametinib (PD-0325901) capsule or dispersible tablet 2 mg/m\^2 (maximum dose of 4 mg) by mouth twice daily
- id
- OG000
- title
- Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901)
- description
- Patients aged 18 and above at the time of informed consent. Mirdametinib (PD-0325901) capsule or dispersible tablet 2 mg/m\^2 (maximum dose of 4 mg) by mouth twice daily
- id
- OG001
- title
- Treatment Phase - Adult Cohort Mirdametinib (PD-0325901)
- param Type
- NUMBER
- population Description
- The Full Analysis Set is defined as patients who received at least one dose of Mirdametinib.
- reporting Status
- POSTED
- time Frame
- Up to 24 months
- title
- Confirmed Objective Response Rate at the End of the Treatment Phase.
- type
- PRIMARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice