TriangleNCT04113018 · OUTCOME
Number of Participants With at Least One Serious Adverse Event
This outcome was registered, but no numerical results were posted in the captured record.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- From enrollment to 30 days following cessation of study treatment. Reasons for study treatment discontinuation include progression, toxicity, consent withdrawal, or investigator decision; assessed for approximately 5 years.
What was measured
A binary variable will be determined for each participant indicating whether or not the subject had at least one adverse event that was categorized as serious, regardless of causality. Serious is defined per the study protocol and includes events that the investigator deems serious and results in the following outcomes: death, life-threatening situation, persistent or significant disability/incapacity, requires or prolongs hospitalization, congenital anomaly/birth defect in the offspring of a study participant, suspected transmission of any infectious agent via medial product, or based upon medical judgement, may jeopardize the subject and may require medical or surgical intervention to prevent one of the afore listed outcomes from occurring.
Groups in this outcome
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denom Units Selected
- Participants
- description
- A binary variable will be determined for each participant indicating whether or not the subject had at least one adverse event that was categorized as serious, regardless of causality. Serious is defined per the study protocol and includes events that the investigator deems serious and results in the following outcomes: death, life-threatening situation, persistent or significant disability/incapacity, requires or prolongs hospitalization, congenital anomaly/birth defect in the offspring of a study participant, suspected transmission of any infectious agent via medial product, or based upon medical judgement, may jeopardize the subject and may require medical or surgical intervention to prevent one of the afore listed outcomes from occurring.
- reporting Status
- NOT_POSTED
- time Frame
- From enrollment to 30 days following cessation of study treatment. Reasons for study treatment discontinuation include progression, toxicity, consent withdrawal, or investigator decision; assessed for approximately 5 years.
- title
- Number of Participants With at Least One Serious Adverse Event
- type
- OTHER_PRE_SPECIFIED
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice