TriangleNCT01847274 · OUTCOME
Number of Participants With Non-serious AEs and SAEs in FE Sub-study
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 2 years, 3 months and 11 days
What was measured
An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events.
Analysis population: Safety Population
Groups in this outcome
FE Niraparib Fasted
Participants received Niraparib 300 mg in fasted condition
FE Niraparib Fed
Participants received Niraparib 300 mg in fed condition
| Group | Source count |
|---|---|
| FE Niraparib Fasted | 16 |
| FE Niraparib Fed | 16 |
Reported measurements
Non-serious AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FE Niraparib Fasted | 4 | Not reported | Not reported | Not reported | Not reported |
| FE Niraparib Fed | 6 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FE Niraparib Fasted | 1 | Not reported | Not reported | Not reported | Not reported |
| FE Niraparib Fed | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 6
- title
- Non-serious AEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 16
- units
- Participants
- description
- An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events.
- groups
- description
- Participants received Niraparib 300 mg in fasted condition
- id
- OG000
- title
- FE Niraparib Fasted
- description
- Participants received Niraparib 300 mg in fed condition
- id
- OG001
- title
- FE Niraparib Fed
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population
- reporting Status
- POSTED
- time Frame
- Up to 2 years, 3 months and 11 days
- title
- Number of Participants With Non-serious AEs and SAEs in FE Sub-study
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice