TriangleNCT04472429 · OUTCOME
Number of Participants With Any TEAE Leading to Discontinuation of Study Drug During the Open-label Monotherapy 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 463 days
What was measured
An 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. AEs that occurred after new anticancer therapy were be excluded.
Analysis population: All participants randomized to placebo plus chemotherapy who received at least 1 dose of placebo and then received at least 1 dose of retifanlimab in the open-label monotherapy period.
Groups in this outcome
Retifanlimab 500 mg Q4W
In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
| Group | Source count |
|---|---|
| Retifanlimab 500 mg Q4W | 77 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Retifanlimab 500 mg Q4W | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 77
- units
- Participants
- description
- An 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. AEs that occurred after new anticancer therapy were be excluded.
- groups
- description
- In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
- id
- OG000
- title
- Retifanlimab 500 mg Q4W
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants randomized to placebo plus chemotherapy who received at least 1 dose of placebo and then received at least 1 dose of retifanlimab in the open-label monotherapy period.
- reporting Status
- POSTED
- time Frame
- up 463 days
- title
- Number of Participants With Any TEAE Leading to Discontinuation of Study Drug During the Open-label Monotherapy Period
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice