TriangleNCT02383589 · OUTCOME
Cumulative Oral Corticosteroid Dose
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- milligram (mg)
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
Analysis population: The mITT population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 TM participants. This population was used in the analyses of efficacy outcomes.
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) | 62 |
| Mycophenolate Mofetil (MMF) | 63 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab (RTX) | 2775.00 | Not reported | 2146.88 | 3610.00 | Not reported |
| Mycophenolate Mofetil (MMF) | 4005.00 | Not reported | 2662.50 | 5815.00 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0005
- statistical Method
- Wilcoxon (Mann-Whitney)
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0005
- statistical Method
- Wilcoxon (Mann-Whitney)
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2146.88
- upper Limit
- 3610.00
- value
- 2775.00
- group Id
- OG001
- lower Limit
- 2662.50
- upper Limit
- 5815.00
- value
- 4005.00
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 63
- units
- Participants
- dispersion Type
- Inter-Quartile Range
- 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
- MEDIAN
- population Description
- The mITT population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 TM participants. This population was used in the analyses of efficacy outcomes.
- reporting Status
- POSTED
- time Frame
- From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
- title
- Cumulative Oral Corticosteroid Dose
- type
- SECONDARY
- unit Of Measure
- milligram (mg)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice