TriangleNCT00299130 · OUTCOME
Percentage of Participants With Low Immunoglobulin Concentrations Pre- and Post-Rituximab Treatment
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 (pre-rituximab), Beginning of the safety follow-up period to the end of the study (approximately 6 years) (post-rituximab)
What was measured
A low immunoglobulin concentration was defined as a concentration below the lower level of normal.
Analysis population: Safety follow-up population: All participants who were randomized and received any part of a rituximab infusion. Number of participants analyzed = participants with available data. "N" indicates the number of participants with non-missing data at each time point.
Groups in this outcome
Rituximab + MTX
Participants received 0.5 g or 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
| Group | Source count |
|---|---|
| Rituximab + MTX | 491 |
Reported measurements
Pre-Rituximab (N=490)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab + MTX | 0.2 | Not reported | Not reported | Not reported | Not reported |
Post-Rituximab (N=491)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab + MTX | 5.1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.2
- title
- Pre-Rituximab (N=490)
- categories
- measurements
- group Id
- OG000
- value
- 5.1
- title
- Post-Rituximab (N=491)
- denoms
- counts
- group Id
- OG000
- value
- 491
- units
- Participants
- description
- A low immunoglobulin concentration was defined as a concentration below the lower level of normal.
- groups
- description
- Participants received 0.5 g or 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
- id
- OG000
- title
- Rituximab + MTX
- param Type
- NUMBER
- population Description
- Safety follow-up population: All participants who were randomized and received any part of a rituximab infusion. Number of participants analyzed = participants with available data. "N" indicates the number of participants with non-missing data at each time point.
- reporting Status
- POSTED
- time Frame
- Baseline (pre-rituximab), Beginning of the safety follow-up period to the end of the study (approximately 6 years) (post-rituximab)
- title
- Percentage of Participants With Low Immunoglobulin Concentrations Pre- and Post-Rituximab Treatment
- type
- POST_HOC
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice