TriangleNCT02383589 · OUTCOME
Percentage of Participants With Adverse Events, Serious Adverse Events, and Corticosteroid-Related Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
What was measured
An adverse event is any untoward medical occurrence in a participant to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment. A serious adverse event is an adverse event that results in death or is life-threatening or requires/prolongs hospitalization or results in persistent/significant disability/incapacity or congenital abnormality/birth defect. Adverse events of Grade 3 of higher are severe and life-threatening adverse events CS-related adverse events - causality as determined by the investigator.
Analysis population: The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug.
Groups in this outcome
Rituximab (RTX)
Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
Mycophenolate Mofetil (MMF)
Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
| Group | Source count |
|---|---|
| Rituximab (RTX) | 67 |
| Mycophenolate Mofetil (MMF) | 68 |
Reported measurements
Participants with AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab (RTX) | 85.1 | Not reported | Not reported | Not reported | Not reported |
| Mycophenolate Mofetil (MMF) | 88.2 | Not reported | Not reported | Not reported | Not reported |
Participants with SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab (RTX) | 22.4 | Not reported | Not reported | Not reported | Not reported |
| Mycophenolate Mofetil (MMF) | 14.7 | Not reported | Not reported | Not reported | Not reported |
Participants with Corticosteroid (CS)-Related AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab (RTX) | 34.3 | Not reported | Not reported | Not reported | Not reported |
| Mycophenolate Mofetil (MMF) | 38.2 | Not reported | Not reported | Not reported | Not reported |
Participants with CS-Related AE Grade 3 or higher
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab (RTX) | 1.5 | Not reported | Not reported | Not reported | Not reported |
| Mycophenolate Mofetil (MMF) | 7.4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 85.1
- group Id
- OG001
- value
- 88.2
- title
- Participants with AE
- categories
- measurements
- group Id
- OG000
- value
- 22.4
- group Id
- OG001
- value
- 14.7
- title
- Participants with SAE
- categories
- measurements
- group Id
- OG000
- value
- 34.3
- group Id
- OG001
- value
- 38.2
- title
- Participants with Corticosteroid (CS)-Related AE
- categories
- measurements
- group Id
- OG000
- value
- 1.5
- group Id
- OG001
- value
- 7.4
- title
- Participants with CS-Related AE Grade 3 or higher
- denoms
- counts
- group Id
- OG000
- value
- 67
- group Id
- OG001
- value
- 68
- units
- Participants
- description
- An adverse event is any untoward medical occurrence in a participant to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment. A serious adverse event is an adverse event that results in death or is life-threatening or requires/prolongs hospitalization or results in persistent/significant disability/incapacity or congenital abnormality/birth defect. Adverse events of Grade 3 of higher are severe and life-threatening adverse events CS-related adverse events - causality as determined by the investigator.
- groups
- description
- Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
- id
- OG000
- title
- Rituximab (RTX)
- description
- Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
- id
- OG001
- title
- Mycophenolate Mofetil (MMF)
- param Type
- NUMBER
- population Description
- The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug.
- reporting Status
- POSTED
- time Frame
- Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
- title
- Percentage of Participants With Adverse Events, Serious Adverse Events, and Corticosteroid-Related Adverse Events
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice