TriangleNCT02411448 · OUTCOME
Number of Participants With Treatment-Emergent Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Cycle 1 Day 1 through End of Study (Up To 3 Years)
What was measured
A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Analysis population: All randomized participants who received at least one dose of study drug.
Groups in this outcome
Part A: Ramucirumab + Erlotinib
Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Part B: Ramucirumab + Erlotinib
Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
Part B: Placebo + Erlotinib
Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
| Group | Source count |
|---|---|
| Part A: Ramucirumab + Erlotinib | 14 |
| Part B: Ramucirumab + Erlotinib | 221 |
| Part B: Placebo + Erlotinib | 225 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: Ramucirumab + Erlotinib | 14 | Not reported | Not reported | Not reported | Not reported |
| Part B: Ramucirumab + Erlotinib | 221 | Not reported | Not reported | Not reported | Not reported |
| Part B: Placebo + Erlotinib | 225 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 221
- group Id
- OG002
- value
- 225
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 221
- group Id
- OG002
- value
- 225
- units
- Participants
- description
- A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
- groups
- description
- Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
- id
- OG000
- title
- Part A: Ramucirumab + Erlotinib
- description
- Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
- id
- OG001
- title
- Part B: Ramucirumab + Erlotinib
- description
- Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
- id
- OG002
- title
- Part B: Placebo + Erlotinib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All randomized participants who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 through End of Study (Up To 3 Years)
- title
- Number of Participants With Treatment-Emergent Adverse Events
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice