TriangleNCT04590963 · OUTCOME
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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
- Day 1 through 21.4 months (maximum observed duration)
What was measured
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first.
Analysis population: The Safety Analysis Set included all participants randomized at least 2 months before the DCO 01Sep2022 (i.e. on or before 01Jul2022).
Groups in this outcome
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
Participants received IV monalizumab 750 mg Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Placebo Q2W + Cetuximab 400 mg/m^2
Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
| Group | Source count |
|---|---|
| Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 | 246 |
| Placebo Q2W + Cetuximab 400 mg/m^2 | 122 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 | 236 | Not reported | Not reported | Not reported | Not reported |
| Placebo Q2W + Cetuximab 400 mg/m^2 | 120 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 236
- group Id
- OG001
- value
- 120
- denoms
- counts
- group Id
- OG000
- value
- 246
- group Id
- OG001
- value
- 122
- units
- Participants
- description
- An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first.
- groups
- description
- Participants received IV monalizumab 750 mg Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
- id
- OG000
- title
- Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
- description
- Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
- id
- OG001
- title
- Placebo Q2W + Cetuximab 400 mg/m^2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The Safety Analysis Set included all participants randomized at least 2 months before the DCO 01Sep2022 (i.e. on or before 01Jul2022).
- reporting Status
- POSTED
- time Frame
- Day 1 through 21.4 months (maximum observed duration)
- title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice