TriangleNCT03434379 · OUTCOME
Number of Participants With Adverse Events (AEs) in the China Population
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 end of study (up to approximately 56 months)
What was measured
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Analysis population: China safety population included all randomized China participants who received any amount of study drug with participants grouped according to the treatment the participant actually received.
Groups in this outcome
Sorafenib - China
Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Atezolizumab + Bevacizumab - Global
Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
| Group | Source count |
|---|---|
| Sorafenib - China | 58 |
| Atezolizumab + Bevacizumab - Global | 132 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sorafenib - China | 56 | Not reported | Not reported | Not reported | Not reported |
| Atezolizumab + Bevacizumab - Global | 131 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 131
- denoms
- counts
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 132
- units
- Participants
- description
- An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
- groups
- description
- Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
- id
- OG000
- title
- Sorafenib - China
- description
- Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
- id
- OG001
- title
- Atezolizumab + Bevacizumab - Global
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- China safety population included all randomized China participants who received any amount of study drug with participants grouped according to the treatment the participant actually received.
- reporting Status
- POSTED
- time Frame
- Up to end of study (up to approximately 56 months)
- title
- Number of Participants With Adverse Events (AEs) in the China Population
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice