Percentage of Participants by Time Spent in the Hospital 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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
What was measured
Hospital time was defined as the amount of time the participant was in the hospital for the course of one cycle of rituximab + CHOP chemotherapy. Where the hospital time was not documented for a given cycle, it was reported as "Missing".
Analysis population: Safety Population.
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
Less than 2 hours (Cycle 1)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
0.3
Not reported
Not reported
Not reported
Not reported
Rituximab IV
0
Not reported
Not reported
Not reported
Not reported
2 to 4 hours (Cycle 1)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
3.0
Not reported
Not reported
Not reported
Not reported
Rituximab IV
1.5
Not reported
Not reported
Not reported
Not reported
4 to 6 hours (Cycle 1)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
19.8
Not reported
Not reported
Not reported
Not reported
Rituximab IV
20.7
Not reported
Not reported
Not reported
Not reported
6 to 12 hours (Cycle 1)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
39.0
Not reported
Not reported
Not reported
Not reported
Rituximab IV
43.8
Not reported
Not reported
Not reported
Not reported
12 to 24 hours (Cycle 1)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
8.9
Not reported
Not reported
Not reported
Not reported
Rituximab IV
6.9
Not reported
Not reported
Not reported
Not reported
More than 24 hours (Cycle 1)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
26.8
Not reported
Not reported
Not reported
Not reported
Rituximab IV
24.1
Not reported
Not reported
Not reported
Not reported
Missing (Cycle 1)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
2.2
Not reported
Not reported
Not reported
Not reported
Rituximab IV
3.0
Not reported
Not reported
Not reported
Not reported
Less than 2 hours (Cycle 2)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
3.8
Not reported
Not reported
Not reported
Not reported
Rituximab IV
0
Not reported
Not reported
Not reported
Not reported
2 to 4 hours (Cycle 2)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
33.1
Not reported
Not reported
Not reported
Not reported
Rituximab IV
10.1
Not reported
Not reported
Not reported
Not reported
4 to 6 hours (Cycle 2)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
27.9
Not reported
Not reported
Not reported
Not reported
Rituximab IV
33.5
Not reported
Not reported
Not reported
Not reported
6 to 12 hours (Cycle 2)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
16.3
Not reported
Not reported
Not reported
Not reported
Rituximab IV
38.8
Not reported
Not reported
Not reported
Not reported
12 to 24 hours (Cycle 2)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
3.8
Not reported
Not reported
Not reported
Not reported
Rituximab IV
1.1
Not reported
Not reported
Not reported
Not reported
More than 24 hours (Cycle 2)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
10.3
Not reported
Not reported
Not reported
Not reported
Rituximab IV
11.7
Not reported
Not reported
Not reported
Not reported
Missing (Cycle 2)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
4.9
Not reported
Not reported
Not reported
Not reported
Rituximab IV
4.8
Not reported
Not reported
Not reported
Not reported
Less Than 2 hours (Cycle 3)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
3.6
Not reported
Not reported
Not reported
Not reported
Rituximab IV
0.5
Not reported
Not reported
Not reported
Not reported
2 to 4 hours (Cycle 3)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
37.2
Not reported
Not reported
Not reported
Not reported
Rituximab IV
11.9
Not reported
Not reported
Not reported
Not reported
4 to 6 hours (Cycle 3)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
30.2
Not reported
Not reported
Not reported
Not reported
Rituximab IV
30.8
Not reported
Not reported
Not reported
Not reported
6 to 12 hours (Cycle 3)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
14.5
Not reported
Not reported
Not reported
Not reported
Rituximab IV
41.6
Not reported
Not reported
Not reported
Not reported
12 to 24 hours (Cycle 3)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
2.8
Not reported
Not reported
Not reported
Not reported
Rituximab IV
2.2
Not reported
Not reported
Not reported
Not reported
More than 24 hours (Cycle 3)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
9.8
Not reported
Not reported
Not reported
Not reported
Rituximab IV
10.3
Not reported
Not reported
Not reported
Not reported
Missing (Cycle 3)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
2.0
Not reported
Not reported
Not reported
Not reported
Rituximab IV
2.7
Not reported
Not reported
Not reported
Not reported
Less Than 2 hours (Cycle 4)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
4.5
Not reported
Not reported
Not reported
Not reported
Rituximab IV
0
Not reported
Not reported
Not reported
Not reported
2 to 4 hours (Cycle 4)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
36.3
Not reported
Not reported
Not reported
Not reported
Rituximab IV
10.0
Not reported
Not reported
Not reported
Not reported
4 to 6 hours (Cycle 4)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
27.5
Not reported
Not reported
Not reported
Not reported
Rituximab IV
31.1
Not reported
Not reported
Not reported
Not reported
6 to 12 hours (Cycle 4)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
17.6
Not reported
Not reported
Not reported
Not reported
Rituximab IV
42.2
Not reported
Not reported
Not reported
Not reported
12 to 24 hours (Cycle 4)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
2.0
Not reported
Not reported
Not reported
Not reported
Rituximab IV
2.8
Not reported
Not reported
Not reported
Not reported
More than 24 hours (Cycle 4)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
10.2
Not reported
Not reported
Not reported
Not reported
Rituximab IV
10.6
Not reported
Not reported
Not reported
Not reported
Missing (Cycle 4)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
2.0
Not reported
Not reported
Not reported
Not reported
Rituximab IV
3.3
Not reported
Not reported
Not reported
Not reported
Less Than 2 hours (Cycle 5)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
5.0
Not reported
Not reported
Not reported
Not reported
Rituximab IV
0.6
Not reported
Not reported
Not reported
Not reported
2 to 4 hours (Cycle 5)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
39.5
Not reported
Not reported
Not reported
Not reported
Rituximab IV
11.5
Not reported
Not reported
Not reported
Not reported
4 to 6 hours (Cycle 5)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
26.4
Not reported
Not reported
Not reported
Not reported
Rituximab IV
34.5
Not reported
Not reported
Not reported
Not reported
6 to 12 hours (Cycle 5)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
16.0
Not reported
Not reported
Not reported
Not reported
Rituximab IV
37.4
Not reported
Not reported
Not reported
Not reported
12 to 24 hours (Cycle 5)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
2.1
Not reported
Not reported
Not reported
Not reported
Rituximab IV
1.7
Not reported
Not reported
Not reported
Not reported
More than 24 hours (Cycle 5)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
8.9
Not reported
Not reported
Not reported
Not reported
Rituximab IV
10.9
Not reported
Not reported
Not reported
Not reported
Missing (Cycle 5)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
2.1
Not reported
Not reported
Not reported
Not reported
Rituximab IV
3.4
Not reported
Not reported
Not reported
Not reported
Less Than 2 hours (Cycle 6)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
4.3
Not reported
Not reported
Not reported
Not reported
Rituximab IV
0.6
Not reported
Not reported
Not reported
Not reported
2 to 4 hours (Cycle 6)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
39.6
Not reported
Not reported
Not reported
Not reported
Rituximab IV
12.6
Not reported
Not reported
Not reported
Not reported
4 to 6 hours (Cycle 6)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
26.4
Not reported
Not reported
Not reported
Not reported
Rituximab IV
34.1
Not reported
Not reported
Not reported
Not reported
6 to 12 hours (Cycle 6)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
16.3
Not reported
Not reported
Not reported
Not reported
Rituximab IV
38.3
Not reported
Not reported
Not reported
Not reported
12 to 24 hours (Cycle 6)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
2.5
Not reported
Not reported
Not reported
Not reported
Rituximab IV
2.4
Not reported
Not reported
Not reported
Not reported
More than 24 hours (Cycle 6)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
8.6
Not reported
Not reported
Not reported
Not reported
Rituximab IV
9.0
Not reported
Not reported
Not reported
Not reported
Missing (Cycle 6)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
2.5
Not reported
Not reported
Not reported
Not reported
Rituximab IV
3.0
Not reported
Not reported
Not reported
Not reported
Less Than 2 hours (Cycle 7)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
17.7
Not reported
Not reported
Not reported
Not reported
Rituximab IV
0
Not reported
Not reported
Not reported
Not reported
2 to 4 hours (Cycle 7)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
40.8
Not reported
Not reported
Not reported
Not reported
Rituximab IV
23.5
Not reported
Not reported
Not reported
Not reported
4 to 6 hours (Cycle 7)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
19.9
Not reported
Not reported
Not reported
Not reported
Rituximab IV
36.4
Not reported
Not reported
Not reported
Not reported
6 to 12 hours (Cycle 7)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
10.4
Not reported
Not reported
Not reported
Not reported
Rituximab IV
30.9
Not reported
Not reported
Not reported
Not reported
12 to 24 hours (Cycle 7)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
2.8
Not reported
Not reported
Not reported
Not reported
Rituximab IV
2.5
Not reported
Not reported
Not reported
Not reported
More than 24 hours (Cycle 7)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
5.7
Not reported
Not reported
Not reported
Not reported
Rituximab IV
3.7
Not reported
Not reported
Not reported
Not reported
Missing (Cycle 7)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
2.5
Not reported
Not reported
Not reported
Not reported
Rituximab IV
3.1
Not reported
Not reported
Not reported
Not reported
Less Than 2 hours (Cycle 8)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
18.0
Not reported
Not reported
Not reported
Not reported
Rituximab IV
0
Not reported
Not reported
Not reported
Not reported
2 to 4 hours (Cycle 8)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
40.5
Not reported
Not reported
Not reported
Not reported
Rituximab IV
25.8
Not reported
Not reported
Not reported
Not reported
4 to 6 hours (Cycle 8)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
21.9
Not reported
Not reported
Not reported
Not reported
Rituximab IV
34.0
Not reported
Not reported
Not reported
Not reported
6 to 12 hours (Cycle 8)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
8.7
Not reported
Not reported
Not reported
Not reported
Rituximab IV
30.8
Not reported
Not reported
Not reported
Not reported
12 to 24 hours (Cycle 8)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
2.6
Not reported
Not reported
Not reported
Not reported
Rituximab IV
1.3
Not reported
Not reported
Not reported
Not reported
More than 24 hours (Cycle 8)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
5.8
Not reported
Not reported
Not reported
Not reported
Rituximab IV
5.0
Not reported
Not reported
Not reported
Not reported
Missing (Cycle 8)
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Rituximab SC
2.6
Not reported
Not reported
Not reported
Not reported
Rituximab IV
3.1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
0.3
group Id
OG001
value
0
title
Less than 2 hours (Cycle 1)
categories
measurements
group Id
OG000
value
3.0
group Id
OG001
value
1.5
title
2 to 4 hours (Cycle 1)
categories
measurements
group Id
OG000
value
19.8
group Id
OG001
value
20.7
title
4 to 6 hours (Cycle 1)
categories
measurements
group Id
OG000
value
39.0
group Id
OG001
value
43.8
title
6 to 12 hours (Cycle 1)
categories
measurements
group Id
OG000
value
8.9
group Id
OG001
value
6.9
title
12 to 24 hours (Cycle 1)
categories
measurements
group Id
OG000
value
26.8
group Id
OG001
value
24.1
title
More than 24 hours (Cycle 1)
categories
measurements
group Id
OG000
value
2.2
group Id
OG001
value
3.0
title
Missing (Cycle 1)
categories
measurements
group Id
OG000
value
3.8
group Id
OG001
value
0
title
Less than 2 hours (Cycle 2)
categories
measurements
group Id
OG000
value
33.1
group Id
OG001
value
10.1
title
2 to 4 hours (Cycle 2)
categories
measurements
group Id
OG000
value
27.9
group Id
OG001
value
33.5
title
4 to 6 hours (Cycle 2)
categories
measurements
group Id
OG000
value
16.3
group Id
OG001
value
38.8
title
6 to 12 hours (Cycle 2)
categories
measurements
group Id
OG000
value
3.8
group Id
OG001
value
1.1
title
12 to 24 hours (Cycle 2)
denoms
counts
group Id
OG000
value
369
group Id
OG001
value
203
units
Participants
description
Hospital time was defined as the amount of time the participant was in the hospital for the course of one cycle of rituximab + CHOP chemotherapy. Where the hospital time was not documented for a given cycle, it was reported as "Missing".
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
NUMBER
population Description
Safety Population.
reporting Status
POSTED
time Frame
Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)
title
Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle
Triangle