NCT03213704 · OUTCOME
Percentage of Patients Experiencing Grade 3 or Higher 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 participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 2 years from study entry
What was measured
Percentage of patients experiencing grade 3 or higher adverse events will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Groups in this outcome
Treatment (Larotrectinib Sulfate)
Patients receive larotrectinib sulfate PO or via NG- or G-tube BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, MRI, an x-ray, bone scan, and/or MIBG scintigraphy during screening and on study. Patients also undergo bone marrow aspiration and/or biopsy during screening and may undergo blood sample collection on study.
| Group | Source count |
|---|---|
| Treatment (Larotrectinib Sulfate) | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Larotrectinib Sulfate) | 44 | Not reported | 13.7 | 78.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.7
- upper Limit
- 78.8
- value
- 44
- denoms
- counts
- group Id
- OG000
- value
- 9
- units
- Participants
- description
- Percentage of patients experiencing grade 3 or higher adverse events will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive larotrectinib sulfate PO or via NG- or G-tube BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, MRI, an x-ray, bone scan, and/or MIBG scintigraphy during screening and on study. Patients also undergo bone marrow aspiration and/or biopsy during screening and may undergo blood sample collection on study.
- id
- OG000
- title
- Treatment (Larotrectinib Sulfate)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 2 years from study entry
- title
- Percentage of Patients Experiencing Grade 3 or Higher Adverse Events
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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