NCT00104299 · OUTCOME
Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy
Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis · Source last updated 2017-04-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Through common close-out (defined as 18 months after the last participant is enrolled in the trial)
What was measured
The adverse event rate for the following events considered related to vasculitis: Death; Grade 2 or higher leukopenia or thrombocytopenia; Grade 3 or higher infections; Hemorrhagic cystitis (grade 2 or lower needs confirmation by cytoscopy); Malignancy; Venous thromboembolic event (deep venous thrombosis or pulmonary embolism); Hospitalization resulting either from the disease or from a complication due to study treatment; Infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions (including cytokine release allergic reaction); Cerebrovascular accident
Analysis population: Safety Sample
Groups in this outcome
Rituximab
Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
Control Group
Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Rituximab | 99 |
|---|
| Control Group | 98 |
|---|
Reported measurements
Death
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Control Group | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2 or Higher Leukopenia
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Control Group | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2 or Higher Thrombocytopenia
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Control Group | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or Higher Infections
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
| Control Group | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
Hemorrhagic Cystitis (Grade 2 or Lower)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Control Group | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Malignancy
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Control Group | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Venous Thromboembolic Event
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Control Group | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Hospitalization Resulting from the Disease
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
| Control Group | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Cerebrovascular Accident (CVA)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Control Group | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Infusion Reactions Leading to Infusion Disc.
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Control Group | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- group Description
- Participant-months are defined as duration in months from the first study drug dosing date to the last date of the participant in the protocol. The rate of selected AEs is defined as the total number of selected AEs divided by total participant-months, and indicates the number of events per participant per month on average. Participants are grouped according to their originally received treatment.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.927
- p Value Comment
- P-value is from the Poisson regression model adjusting for clinical study site and ANCA type. The natural logarithm of participant-months is used as an offset in this model
- statistical Method
- Poisson regression model
Complete source fields
- analyses
- group Description
- Participant-months are defined as duration in months from the first study drug dosing date to the last date of the participant in the protocol. The rate of selected AEs is defined as the total number of selected AEs divided by total participant-months, and indicates the number of events per participant per month on average. Participants are grouped according to their originally received treatment.
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.927
- p Value Comment
- P-value is from the Poisson regression model adjusting for clinical study site and ANCA type. The natural logarithm of participant-months is used as an offset in this model
- statistical Method
- Poisson regression model
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- title
- Death
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 23
- title
- Grade 2 or Higher Leukopenia
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- title
- Grade 2 or Higher Thrombocytopenia
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 16
- title
- Grade 3 or Higher Infections
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Hemorrhagic Cystitis (Grade 2 or Lower)
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 2
- title
- Malignancy
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 8
- title
- Venous Thromboembolic Event
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 7
- title
- Hospitalization Resulting from the Disease
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- Cerebrovascular Accident (CVA)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Infusion Reactions Leading to Infusion Disc.
- denoms
- counts
- group Id
- OG000
- value
- 99
- group Id
- OG001
- value
- 98
- units
- Participants
- description
- The adverse event rate for the following events considered related to vasculitis: Death; Grade 2 or higher leukopenia or thrombocytopenia; Grade 3 or higher infections; Hemorrhagic cystitis (grade 2 or lower needs confirmation by cytoscopy); Malignancy; Venous thromboembolic event (deep venous thrombosis or pulmonary embolism); Hospitalization resulting either from the disease or from a complication due to study treatment; Infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions (including cytokine release allergic reaction); Cerebrovascular accident
- groups
- description
- Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
- id
- OG000
- title
- Rituximab
- description
- Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
- id
- OG001
- title
- Control Group
- param Type
- NUMBER
- population Description
- Safety Sample
- reporting Status
- POSTED
- time Frame
- Through common close-out (defined as 18 months after the last participant is enrolled in the trial)
- title
- Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy
- type
- SECONDARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice
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