TriangleNCT01808573 · OUTCOME
Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious 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
- Not reported
- Time frame
- From first dose through last dose + 28 days, up to 41 months. The result is based on final data cut.
What was measured
Adverse Events to be measured are Treatment-Emergent and Serious AEs that occurred on or after first dose of investigational product and up to 28 days after the last dose
Analysis population: Safety population: Participants receiving at least 1 dose of investigational product.
Groups in this outcome
Neratinib Plus Capecitabine
neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
Lapatinib Plus Capecitabine
lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
| Group | Source count |
|---|---|
| Neratinib Plus Capecitabine | 303 |
| Lapatinib Plus Capecitabine | 311 |
Reported measurements
All Treatment-Emergent Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Neratinib Plus Capecitabine | 99.7 | Not reported | Not reported | Not reported | Not reported |
| Lapatinib Plus Capecitabine | 99.4 | Not reported | Not reported | Not reported | Not reported |
Serious Treatment-Emergent Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Neratinib Plus Capecitabine | 34.0 | Not reported | Not reported | Not reported | Not reported |
| Lapatinib Plus Capecitabine | 29.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 99.7
- group Id
- OG001
- value
- 99.4
- title
- All Treatment-Emergent Adverse Events
- categories
- measurements
- group Id
- OG000
- value
- 34.0
- group Id
- OG001
- value
- 29.9
- title
- Serious Treatment-Emergent Adverse Events
- denoms
- counts
- group Id
- OG000
- value
- 303
- group Id
- OG001
- value
- 311
- units
- Participants
- description
- Adverse Events to be measured are Treatment-Emergent and Serious AEs that occurred on or after first dose of investigational product and up to 28 days after the last dose
- groups
- description
- neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
- id
- OG000
- title
- Neratinib Plus Capecitabine
- description
- lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
- id
- OG001
- title
- Lapatinib Plus Capecitabine
- param Type
- NUMBER
- population Description
- Safety population: Participants receiving at least 1 dose of investigational product.
- reporting Status
- POSTED
- time Frame
- From first dose through last dose + 28 days, up to 41 months. The result is based on final data cut.
- title
- Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice