TriangleNCT01613599 · OUTCOME
Incidence Rate of Serious Vascular Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- events per 100 patient year
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
What was measured
A serious vascular adverse event was defined as a SAE coded to the MedDRA vascular system organ class. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.
Analysis population: The safety population included all participants who received any active dose of rituximab.
Groups in this outcome
Rituximab
Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
| Group | Source count |
|---|---|
| Rituximab | 97 |
| Group | Source count |
|---|---|
| Rituximab | 338 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 2.37 | Not reported | 1.02 | 4.67 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.02
- upper Limit
- 4.67
- value
- 2.37
- denom Units Selected
- Total Patient-years at Risk
- denoms
- counts
- group Id
- OG000
- value
- 97
- units
- Participants
- counts
- group Id
- OG000
- value
- 338
- units
- Total Patient-years at Risk
- description
- A serious vascular adverse event was defined as a SAE coded to the MedDRA vascular system organ class. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
- id
- OG000
- title
- Rituximab
- param Type
- NUMBER
- population Description
- The safety population included all participants who received any active dose of rituximab.
- reporting Status
- POSTED
- time Frame
- From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
- title
- Incidence Rate of Serious Vascular Adverse Events
- type
- SECONDARY
- type Units Analyzed
- Total Patient-years at Risk
- unit Of Measure
- events per 100 patient year
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice