TriangleNCT03190915 · OUTCOME
Incidence of Adverse Events
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 cycle 12 (1 cycle = 28 days)
What was measured
Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will report the percentage of patients within each disease stratum who experienced a grade 3 or higher toxicity with attribution of possible, probable, or definite while on protocol therapy or within 30 days of the last dose of therapy.
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) | 30.0 | Not reported | 6.7 | 65.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.7
- upper Limit
- 65.2
- value
- 30.0
- denoms
- counts
- group Id
- OG000
- value
- 10
- units
- Participants
- description
- Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will report the percentage of patients within each disease stratum who experienced a grade 3 or higher toxicity with attribution of possible, probable, or definite while on protocol therapy or within 30 days of the last dose of therapy.
- 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
- Up to cycle 12 (1 cycle = 28 days)
- title
- Incidence of Adverse Events
- type
- SECONDARY
- unit Of Measure
- Percentage of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice