TriangleNCT01613599 · OUTCOME
Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab
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 infection was defined as an infection that was a serious adverse event (SAE) or a non-SAE infection that required treatment with intravenous antimicrobials. 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 re-treated safety population was a subset of the safety population and included all participants who received more than one course 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 | 71 |
| Group | Source count |
|---|---|
| Rituximab | 264 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 6.07 | Not reported | 3.47 | 9.86 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.47
- upper Limit
- 9.86
- value
- 6.07
- denom Units Selected
- Total Patient-years at Risk
- denoms
- counts
- group Id
- OG000
- value
- 71
- units
- Participants
- counts
- group Id
- OG000
- value
- 264
- units
- Total Patient-years at Risk
- description
- A serious infection was defined as an infection that was a serious adverse event (SAE) or a non-SAE infection that required treatment with intravenous antimicrobials. 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 re-treated safety population was a subset of the safety population and included all participants who received more than one course 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 Infections in Participants Who Received Re-treatment With MabThera/Rituximab
- 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