TriangleNCT03190915 · OUTCOME
Objective Response
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
- 12 cycles (1 cycle = 28 days)
What was measured
Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed accounting for the two-stage design. A responder is defined as a patient who achieves a best response of PR or CR on the study prior to having an overall response of PD; all others will be considered non-responders. The definitions of response are based on a publication (PMID: 25552679) entitled "Criteria for evaluating response and outcome in clinical trials for children with juvenile myelomonocytic leukemia". Patients can be categorized as having experienced complete remission, partial remission, stable disease, or progressive disease based on a combination of clinical and molecular variables.
Analysis population: All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1521 protocol.
Groups in this outcome
Treatment (Trametinib)
Patients receive trametinib PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a bone marrow aspiration or biopsy at baseline, on day 28 of cycles 1 and 2, at all subsequent odd numbered cycles, and at end of treatment.
| Group | Source count |
|---|---|
| Treatment (Trametinib) | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Trametinib) | 50.0 | Not reported | 18.7 | 81.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.7
- upper Limit
- 81.3
- value
- 50.0
- denoms
- counts
- group Id
- OG000
- value
- 10
- units
- Participants
- description
- Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed accounting for the two-stage design. A responder is defined as a patient who achieves a best response of PR or CR on the study prior to having an overall response of PD; all others will be considered non-responders. The definitions of response are based on a publication (PMID: 25552679) entitled "Criteria for evaluating response and outcome in clinical trials for children with juvenile myelomonocytic leukemia". Patients can be categorized as having experienced complete remission, partial remission, stable disease, or progressive disease based on a combination of clinical and molecular variables.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive trametinib PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a bone marrow aspiration or biopsy at baseline, on day 28 of cycles 1 and 2, at all subsequent odd numbered cycles, and at end of treatment.
- id
- OG000
- title
- Treatment (Trametinib)
- param Type
- NUMBER
- population Description
- All patients who met the evaluable for response criteria outlined in section 9.4 of the ADVL1521 protocol.
- reporting Status
- POSTED
- time Frame
- 12 cycles (1 cycle = 28 days)
- title
- Objective Response
- type
- PRIMARY
- unit Of Measure
- Percentage of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice