NCT01649856 · OUTCOME

Percentage of Participants by Time Spent in the Infusion Chair/Bed 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

Chair time was defined as the amount of time the participant occupied an infusion chair/bed for a single treatment cycle of rituximab + CHOP chemotherapy. Where the chair 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 30 minutes (Cycle 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	0	Not reported	Not reported	Not reported	Not reported
Rituximab IV	0	Not reported	Not reported	Not reported	Not reported

30 minutes to 1 hour (Cycle 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	0	Not reported	Not reported	Not reported	Not reported
Rituximab IV	0.5	Not reported	Not reported	Not reported	Not reported

1 to 2 hours (Cycle 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	1.4	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	20.6	Not reported	Not reported	Not reported	Not reported
Rituximab IV	17.2	Not reported	Not reported	Not reported	Not reported

4 to 12 hours (Cycle 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	69.4	Not reported	Not reported	Not reported	Not reported
Rituximab IV	72.4	Not reported	Not reported	Not reported	Not reported

More than 12 hours (Cycle 1)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	7.3	Not reported	Not reported	Not reported	Not reported
Rituximab IV	7.9	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	1.4	Not reported	Not reported	Not reported	Not reported
Rituximab IV	2.0	Not reported	Not reported	Not reported	Not reported

Less than 30 minutes (Cycle 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	7.3	Not reported	Not reported	Not reported	Not reported
Rituximab IV	0	Not reported	Not reported	Not reported	Not reported

30 minutes to 1 hour (Cycle 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	2.4	Not reported	Not reported	Not reported	Not reported
Rituximab IV	0	Not reported	Not reported	Not reported	Not reported

1 to 2 hours (Cycle 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	17.1	Not reported	Not reported	Not reported	Not reported
Rituximab IV	1.1	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	56.1	Not reported	Not reported	Not reported	Not reported
Rituximab IV	36.2	Not reported	Not reported	Not reported	Not reported

4 to 12 hours (Cycle 2)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	12.2	Not reported	Not reported	Not reported	Not reported
Rituximab IV	60.1	Not reported	Not reported	Not reported	Not reported

More than 12 hours (Cycle 2)

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	1.1	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	4.6	Not reported	Not reported	Not reported	Not reported
Rituximab IV	1.6	Not reported	Not reported	Not reported	Not reported

Less than 30 minutes (Cycle 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	5.6	Not reported	Not reported	Not reported	Not reported
Rituximab IV	0	Not reported	Not reported	Not reported	Not reported

30 minutes to 1 hour (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	0	Not reported	Not reported	Not reported	Not reported

1 to 2 hours (Cycle 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	22.1	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	55.9	Not reported	Not reported	Not reported	Not reported
Rituximab IV	38.9	Not reported	Not reported	Not reported	Not reported

4 to 12 hours (Cycle 3)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	12.6	Not reported	Not reported	Not reported	Not reported
Rituximab IV	58.4	Not reported	Not reported	Not reported	Not reported

More than 12 hours (Cycle 3)

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	0.5	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	1.7	Not reported	Not reported	Not reported	Not reported
Rituximab IV	1.6	Not reported	Not reported	Not reported	Not reported

Less than 30 minutes (Cycle 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	5.1	Not reported	Not reported	Not reported	Not reported
Rituximab IV	0	Not reported	Not reported	Not reported	Not reported

30 minutes to 1 hour (Cycle 4)

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	0	Not reported	Not reported	Not reported	Not reported

1 to 2 hours (Cycle 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	21.8	Not reported	Not reported	Not reported	Not reported
Rituximab IV	1.1	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	55.0	Not reported	Not reported	Not reported	Not reported
Rituximab IV	36.7	Not reported	Not reported	Not reported	Not reported

4 to 12 hours (Cycle 4)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	13.9	Not reported	Not reported	Not reported	Not reported
Rituximab IV	60.6	Not reported	Not reported	Not reported	Not reported

More than 12 hours (Cycle 4)

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	0.6	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	1.1	Not reported	Not reported	Not reported	Not reported
Rituximab IV	1.1	Not reported	Not reported	Not reported	Not reported

Less than 30 minutes (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

30 minutes to 1 hour (Cycle 5)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	2.4	Not reported	Not reported	Not reported	Not reported
Rituximab IV	0	Not reported	Not reported	Not reported	Not reported

1 to 2 hours (Cycle 5)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	25.2	Not reported	Not reported	Not reported	Not reported
Rituximab IV	1.1	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	53.4	Not reported	Not reported	Not reported	Not reported
Rituximab IV	40.2	Not reported	Not reported	Not reported	Not reported

4 to 12 hours (Cycle 5)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	12.8	Not reported	Not reported	Not reported	Not reported
Rituximab IV	56.3	Not reported	Not reported	Not reported	Not reported

More than 12 hours (Cycle 5)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	0	Not reported	Not reported	Not reported	Not reported
Rituximab IV	0.6	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	1.2	Not reported	Not reported	Not reported	Not reported
Rituximab IV	1.1	Not reported	Not reported	Not reported	Not reported

Less than 30 minutes (Cycle 6)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	3.4	Not reported	Not reported	Not reported	Not reported
Rituximab IV	0.6	Not reported	Not reported	Not reported	Not reported

30 minutes to 1 hour (Cycle 6)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	3.1	Not reported	Not reported	Not reported	Not reported
Rituximab IV	0	Not reported	Not reported	Not reported	Not reported

1 to 2 hours (Cycle 6)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	23.0	Not reported	Not reported	Not reported	Not reported
Rituximab IV	1.8	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	56.7	Not reported	Not reported	Not reported	Not reported
Rituximab IV	42.5	Not reported	Not reported	Not reported	Not reported

4 to 12 hours (Cycle 6)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	12.3	Not reported	Not reported	Not reported	Not reported
Rituximab IV	53.3	Not reported	Not reported	Not reported	Not reported

More than 12 hours (Cycle 6)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	0	Not reported	Not reported	Not reported	Not reported
Rituximab IV	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	1.5	Not reported	Not reported	Not reported	Not reported
Rituximab IV	1.8	Not reported	Not reported	Not reported	Not reported

Less than 30 minutes (Cycle 7)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	18.7	Not reported	Not reported	Not reported	Not reported
Rituximab IV	0	Not reported	Not reported	Not reported	Not reported

30 minutes to 1 hour (Cycle 7)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	7.0	Not reported	Not reported	Not reported	Not reported
Rituximab IV	0	Not reported	Not reported	Not reported	Not reported

1 to 2 hours (Cycle 7)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	26.9	Not reported	Not reported	Not reported	Not reported
Rituximab IV	4.9	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	40.2	Not reported	Not reported	Not reported	Not reported
Rituximab IV	48.8	Not reported	Not reported	Not reported	Not reported

4 to 12 hours (Cycle 7)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	6.0	Not reported	Not reported	Not reported	Not reported
Rituximab IV	44.4	Not reported	Not reported	Not reported	Not reported

More than 12 hours (Cycle 7)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	0	Not reported	Not reported	Not reported	Not reported
Rituximab IV	0	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	1.3	Not reported	Not reported	Not reported	Not reported
Rituximab IV	1.9	Not reported	Not reported	Not reported	Not reported

Less than 30 minutes (Cycle 8)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	20.3	Not reported	Not reported	Not reported	Not reported
Rituximab IV	0.6	Not reported	Not reported	Not reported	Not reported

30 minutes to 1 hour (Cycle 8)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	6.4	Not reported	Not reported	Not reported	Not reported
Rituximab IV	0	Not reported	Not reported	Not reported	Not reported

1 to 2 hours (Cycle 8)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	29.3	Not reported	Not reported	Not reported	Not reported
Rituximab IV	4.4	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	36.7	Not reported	Not reported	Not reported	Not reported
Rituximab IV	50.9	Not reported	Not reported	Not reported	Not reported

4 to 12 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	43.4	Not reported	Not reported	Not reported	Not reported

More than 12 hours (Cycle 8)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab SC	0	Not reported	Not reported	Not reported	Not reported
Rituximab IV	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	1.6	Not reported	Not reported	Not reported	Not reported
Rituximab IV	0.6	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Less than 30 minutes (Cycle 1)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0.5
title
30 minutes to 1 hour (Cycle 1)
categories
measurements
group Id
OG000
value
1.4
group Id
OG001
value
0
title
1 to 2 hours (Cycle 1)
categories
measurements
group Id
OG000
value
20.6
group Id
OG001
value
17.2
title
2 to 4 hours (Cycle 1)
categories
measurements
group Id
OG000
value
69.4
group Id
OG001
value
72.4
title
4 to 12 hours (Cycle 1)
categories
measurements
group Id
OG000
value
7.3
group Id
OG001
value
7.9
title
More than 12 hours (Cycle 1)
categories
measurements
group Id
OG000
value
1.4
group Id
OG001
value
2.0
title
Missing (Cycle 1)
categories
measurements
group Id
OG000
value
7.3
group Id
OG001
value
0
title
Less than 30 minutes (Cycle 2)
categories
measurements
group Id
OG000
value
2.4
group Id
OG001
value
0
title
30 minutes to 1 hour (Cycle 2)
categories
measurements
group Id
OG000
value
17.1
group Id
OG001
value
1.1
title
1 to 2 hours (Cycle 2)
categories
measurements
group Id
OG000
value
56.1
group Id
OG001
value
36.2
title
2 to 4 hours (Cycle 2)
categories
measurements
group Id
OG000
value
12.2
group Id
OG001
value
60.1
title
4 to 12 hours (Cycle 2)

denoms

counts
group Id
OG000
value
369
group Id
OG001
value
203
units
Participants

description

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 Infusion Chair/Bed for Each Treatment Cycle

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice