TriangleNCT03599713 · OUTCOME
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
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 846 days (up to approximately 2.3 years)
What was measured
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can 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. A TEAE was defined as either an AE reported for the first time or a worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug. An AE with onset on/after starting a new anticancer therapy was not summarized as a TEAE.
Analysis population: Safety Evaluable Population
Groups in this outcome
Chemotherapy: Naïve
Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W).
Chemotherapy: Refractory
Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.
| Group | Source count |
|---|---|
| Chemotherapy: Naïve | 101 |
| Chemotherapy: Refractory | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemotherapy: Naïve | 92 | Not reported | Not reported | Not reported | Not reported |
| Chemotherapy: Refractory | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 101
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can 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. A TEAE was defined as either an AE reported for the first time or a worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug. An AE with onset on/after starting a new anticancer therapy was not summarized as a TEAE.
- groups
- description
- Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W).
- id
- OG000
- title
- Chemotherapy: Naïve
- description
- Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.
- id
- OG001
- title
- Chemotherapy: Refractory
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Evaluable Population
- reporting Status
- POSTED
- time Frame
- up to 846 days (up to approximately 2.3 years)
- title
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice