NCT01292603 · OUTCOME
Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV
A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia · Source last updated 2018-12-19
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants in the survey
- Interval / dispersion
- Not reported
- Time frame
- Days 4-5 in Cycle 6
What was measured
Physicians and nurses who administered rituximab were asked to answer the following question: "Which formulation of rituximab (SC or IV) do you think is more convenient?" with pre-specified responses as below. Percentage of participants with specified answers were reported. The number of nurses that responded for both the IV and SC arms was 70. The number of physicians that responded for the IV and SC arms were 78 and 81 respectively.
Analysis population: All the physicians and nurses who responded to the questionnaire were included in the analysis.
Groups in this outcome
Part 2 : Rituximab IV 500 mg/m^2
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
Part 2: Rituximab SC 1600 mg
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
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 |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 78 |
|---|
| Part 2: Rituximab SC 1600 mg | 81 |
|---|
Reported measurements
Nurse: Rituximab SC is much more convenient
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 81.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 77.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Nurse: Rituximab SC is a little more convenient
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 7.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 9.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Nurse: Both formulations are equally convenient
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 9.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 4.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Nurse: Rituximab IV is a little more convenient
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 3.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 10.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Nurse: Rituximab IV is much more convenient
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Physician: Rituximab SC is much more convenient
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 78.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 80.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Physician: Rituximab SC a little more convenient
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 15.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 14.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Physician: Both formulations equally convenient
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 6.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 6.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Physician: Rituximab IV a little more convenient
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Physician: Rituximab IV is much more convenient
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 81.0
- group Id
- OG001
- value
- 77.0
- title
- Nurse: Rituximab SC is much more convenient
- categories
- measurements
- group Id
- OG000
- value
- 7.0
- group Id
- OG001
- value
- 9.0
- title
- Nurse: Rituximab SC is a little more convenient
- categories
- measurements
- group Id
- OG000
- value
- 9.0
- group Id
- OG001
- value
- 4.0
- title
- Nurse: Both formulations are equally convenient
- categories
- measurements
- group Id
- OG000
- value
- 3.0
- group Id
- OG001
- value
- 10.0
- title
- Nurse: Rituximab IV is a little more convenient
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- title
- Nurse: Rituximab IV is much more convenient
- categories
- measurements
- group Id
- OG000
- value
- 78.0
- group Id
- OG001
- value
- 80.0
- title
- Physician: Rituximab SC is much more convenient
- categories
- measurements
- group Id
- OG000
- value
- 15.0
- group Id
- OG001
- value
- 14.0
- title
- Physician: Rituximab SC a little more convenient
- categories
- measurements
- group Id
- OG000
- value
- 6.0
- group Id
- OG001
- value
- 6.0
- title
- Physician: Both formulations equally convenient
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- title
- Physician: Rituximab IV a little more convenient
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- title
- Physician: Rituximab IV is much more convenient
- denoms
- counts
- group Id
- OG000
- value
- 78
- group Id
- OG001
- value
- 81
- units
- Participants
- description
- Physicians and nurses who administered rituximab were asked to answer the following question: "Which formulation of rituximab (SC or IV) do you think is more convenient?" with pre-specified responses as below. Percentage of participants with specified answers were reported. The number of nurses that responded for both the IV and SC arms was 70. The number of physicians that responded for the IV and SC arms were 78 and 81 respectively.
- groups
- description
- Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
- id
- OG000
- title
- Part 2 : Rituximab IV 500 mg/m^2
- description
- Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
- id
- OG001
- title
- Part 2: Rituximab SC 1600 mg
- param Type
- NUMBER
- population Description
- All the physicians and nurses who responded to the questionnaire were included in the analysis.
- reporting Status
- POSTED
- time Frame
- Days 4-5 in Cycle 6
- title
- Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV
- type
- SECONDARY
- unit Of Measure
- percentage of participants in the survey
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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