NCT01649856 · OUTCOME
Median Duration of Rituximab Administration for Each Treatment Cycle
A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma · Source last updated 2017-10-11
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours
- Interval / dispersion
- Full Range
- Time frame
- Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
What was measured
Duration of rituximab administration was defined as the time from start to end of the SC injection or IV infusion. The median duration was reported.
Analysis population: Safety Population; n = number of participants in the analysis for the specified timepoint.
Groups in this outcome
Rituximab SC
Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
Rituximab IV
Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
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 SC | 369 |
|---|
| Rituximab IV | 203 |
|---|
Reported measurements
Cycle 1 (n=346,190)
Values in hours · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab SC | 4.0 | Not reported | 0.10 | 11.00 | Not reported |
|---|
| Rituximab IV | 4.0 | Not reported | 1.20 | 10.00 | Not reported |
|---|
Cycle 2 (n=361,178)
Values in hours · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab SC | 0.1 | Not reported | 0.10 | 23.10 | Not reported |
|---|
| Rituximab IV | 3.0 | Not reported | 0.50 | 10.00 | Not reported |
|---|
Cycle 3 (n=349,177)
Values in hours · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab SC | 0.1 | Not reported | 0.10 | 5.50 | Not reported |
|---|
| Rituximab IV | 2.8 | Not reported | 1.00 | 21.40 | Not reported |
|---|
Cycle 4 (n=346,173)
Values in hours · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab SC | 0.1 | Not reported | 0.00 | 2.50 | Not reported |
|---|
| Rituximab IV | 2.7 | Not reported | 0.50 | 8.00 | Not reported |
|---|
Cycle 5 (n=332,165)
Values in hours · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab SC | 0.1 | Not reported | 0.00 | 2.50 | Not reported |
|---|
| Rituximab IV | 2.6 | Not reported | 0.10 | 8.10 | Not reported |
|---|
Cycle 6 (n=319,162)
Values in hours · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab SC | 0.1 | Not reported | 0.00 | 2.50 | Not reported |
|---|
| Rituximab IV | 2.7 | Not reported | 0.10 | 20.00 | Not reported |
|---|
Cycle 7 (n=304,156)
Values in hours · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab SC | 0.1 | Not reported | 0.00 | 23.60 | Not reported |
|---|
| Rituximab IV | 2.7 | Not reported | 0.50 | 6.70 | Not reported |
|---|
Cycle 8 (n=305,152)
Values in hours · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab SC | 0.1 | Not reported | 0.00 | 2.50 | Not reported |
|---|
| Rituximab IV | 2.55 | Not reported | 0.10 | 17.90 | Not reported |
|---|
Overall (n=368,201)
Values in hours · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Rituximab SC | 4.7 | Not reported | 0.10 | 28.70 | Not reported |
|---|
| Rituximab IV | 19.00 | Not reported | 1.20 | 57.40 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.10
- upper Limit
- 11.00
- value
- 4.0
- group Id
- OG001
- lower Limit
- 1.20
- upper Limit
- 10.00
- value
- 4.0
- title
- Cycle 1 (n=346,190)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.10
- upper Limit
- 23.10
- value
- 0.1
- group Id
- OG001
- lower Limit
- 0.50
- upper Limit
- 10.00
- value
- 3.0
- title
- Cycle 2 (n=361,178)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.10
- upper Limit
- 5.50
- value
- 0.1
- group Id
- OG001
- lower Limit
- 1.00
- upper Limit
- 21.40
- value
- 2.8
- title
- Cycle 3 (n=349,177)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 2.50
- value
- 0.1
- group Id
- OG001
- lower Limit
- 0.50
- upper Limit
- 8.00
- value
- 2.7
- title
- Cycle 4 (n=346,173)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 2.50
- value
- 0.1
- group Id
- OG001
- lower Limit
- 0.10
- upper Limit
- 8.10
- value
- 2.6
- title
- Cycle 5 (n=332,165)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 2.50
- value
- 0.1
- group Id
- OG001
- lower Limit
- 0.10
- upper Limit
- 20.00
- value
- 2.7
- title
- Cycle 6 (n=319,162)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 23.60
- value
- 0.1
- group Id
- OG001
- lower Limit
- 0.50
- upper Limit
- 6.70
- value
- 2.7
- title
- Cycle 7 (n=304,156)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 2.50
- value
- 0.1
- group Id
- OG001
- lower Limit
- 0.10
- upper Limit
- 17.90
- value
- 2.55
- title
- Cycle 8 (n=305,152)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.10
- upper Limit
- 28.70
- value
- 4.7
- group Id
- OG001
- lower Limit
- 1.20
- upper Limit
- 57.40
- value
- 19.00
- title
- Overall (n=368,201)
- denoms
- counts
- group Id
- OG000
- value
- 369
- group Id
- OG001
- value
- 203
- units
- Participants
- description
- Duration of rituximab administration was defined as the time from start to end of the SC injection or IV infusion. The median duration was reported.
- dispersion Type
- Full Range
- groups
- description
- Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
- id
- OG000
- title
- Rituximab SC
- description
- Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
- id
- OG001
- title
- Rituximab IV
- param Type
- MEDIAN
- population Description
- Safety Population; n = number of participants in the analysis for the specified timepoint.
- reporting Status
- POSTED
- time Frame
- Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
- title
- Median Duration of Rituximab Administration for Each Treatment Cycle
- type
- SECONDARY
- unit Of Measure
- hours
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