TriangleNCT01847274 · OUTCOME
Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
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 7 years, 7 months and 6 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. Data presented for this outcome measure is based on the data cut-off date of 31-March-2021, which aligns with the time of the study unblinding.
Analysis population: Safety Population consisted of all participants who ingested any amount of study drug.
Groups in this outcome
gBRCA Niraparib
Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
gBRCA Placebo
Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
Non-gBRCA Niraparib
Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
Non-gBRCA Placebo
Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
| Group | Source count |
|---|---|
| gBRCA Niraparib | 136 |
| gBRCA Placebo | 65 |
| Non-gBRCA Niraparib | 231 |
| Non-gBRCA Placebo | 114 |
Reported measurements
Non-serious AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| gBRCA Niraparib | 136 | Not reported | Not reported | Not reported | Not reported |
| gBRCA Placebo | 62 | Not reported | Not reported | Not reported | Not reported |
| Non-gBRCA Niraparib | 231 | Not reported | Not reported | Not reported | Not reported |
| Non-gBRCA Placebo | 110 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| gBRCA Niraparib | 51 | Not reported | Not reported | Not reported | Not reported |
| gBRCA Placebo | 9 | Not reported | Not reported | Not reported | Not reported |
| Non-gBRCA Niraparib | 76 | Not reported | Not reported | Not reported | Not reported |
| Non-gBRCA Placebo | 20 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 136
- group Id
- OG001
- value
- 62
- group Id
- OG002
- value
- 231
- group Id
- OG003
- value
- 110
- title
- Non-serious AEs
- categories
- measurements
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 76
- group Id
- OG003
- value
- 20
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 136
- group Id
- OG001
- value
- 65
- group Id
- OG002
- value
- 231
- group Id
- OG003
- value
- 114
- 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. Data presented for this outcome measure is based on the data cut-off date of 31-March-2021, which aligns with the time of the study unblinding.
- groups
- description
- Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
- id
- OG000
- title
- gBRCA Niraparib
- description
- Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
- id
- OG001
- title
- gBRCA Placebo
- description
- Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
- id
- OG002
- title
- Non-gBRCA Niraparib
- description
- Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
- id
- OG003
- title
- Non-gBRCA Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population consisted of all participants who ingested any amount of study drug.
- reporting Status
- POSTED
- time Frame
- Up to 7 years, 7 months and 6 days
- title
- Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice