TriangleNCT04472429 · OUTCOME
Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) During the Randomized Period
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
- up to 535 days
What was measured
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo, or within 30 days of the last chemotherapy. AEs that occurred after new anticancer therapy were be excluded.
Analysis population: Safety Population: all randomized participants who received at least 1 dose of study treatment. Treatment groups for this population were determined according to the actual treatment the participant received regardless of treatment assignment at randomization.
Groups in this outcome
Retifanlimab 500 mg Q4W + Chemotherapy
Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
Placebo + Chemotherapy
Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
| Group | Source count |
|---|---|
| Retifanlimab 500 mg Q4W + Chemotherapy | 154 |
| Placebo + Chemotherapy | 152 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Retifanlimab 500 mg Q4W + Chemotherapy | 154 | Not reported | Not reported | Not reported | Not reported |
| Placebo + Chemotherapy | 152 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 154
- group Id
- OG001
- value
- 152
- denoms
- counts
- group Id
- OG000
- value
- 154
- group Id
- OG001
- value
- 152
- units
- Participants
- description
- An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo, or within 30 days of the last chemotherapy. AEs that occurred after new anticancer therapy were be excluded.
- groups
- description
- Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
- id
- OG000
- title
- Retifanlimab 500 mg Q4W + Chemotherapy
- description
- Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
- id
- OG001
- title
- Placebo + Chemotherapy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population: all randomized participants who received at least 1 dose of study treatment. Treatment groups for this population were determined according to the actual treatment the participant received regardless of treatment assignment at randomization.
- reporting Status
- POSTED
- time Frame
- up to 535 days
- title
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) During the Randomized Period
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice