NCT01649856 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Up to approximately 4.25 years
Other-event reporting threshold: 5%

Safety Population.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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.	155 / 369	319 / 369	Not reported / Not reported
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.	77 / 203	172 / 203	Not reported / Not reported

Group identifiers: EG000: Rituximab SC · EG001: Rituximab IV

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
49
num At Risk
369
group Id
EG001
num Affected
24
num At Risk
203
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
22
num At Risk
369
group Id
EG001
num Affected
10
num At Risk
203
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
2
num At Risk
369
group Id
EG001
num Affected
2
num At Risk
203
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
369
group Id
EG001
num Affected
3
num At Risk
203
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
0
num At Risk
369
group Id
EG001
num Affected
1
num At Risk
203
term
Febrile bone marrow aplasia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
369
group Id
EG001
num Affected
0
num At Risk
203
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
27
num At Risk
369
group Id
EG001
num Affected
7
num At Risk
203
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
3
num At Risk
369
group Id
EG001
num Affected
3
num At Risk
203
term
Septic shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
4
num At Risk
369
group Id
EG001
num Affected
1
num At Risk
203
term
Lung infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
2
num At Risk
369
group Id
EG001
num Affected
0
num At Risk
203
term
Respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
5
num At Risk
369
group Id
EG001
num Affected
0
num At Risk
203
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
2
num At Risk
369
group Id
EG001
num Affected
0
num At Risk
203
term
Cellulitis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
104
num At Risk
369
group Id
EG001
num Affected
54
num At Risk
203
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
88
num At Risk
369
group Id
EG001
num Affected
40
num At Risk
203
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
79
num At Risk
369
group Id
EG001
num Affected
47
num At Risk
203
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
56
num At Risk
369
group Id
EG001
num Affected
34
num At Risk
203
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
52
num At Risk
369
group Id
EG001
num Affected
20
num At Risk
203
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
40
num At Risk
369
group Id
EG001
num Affected
17
num At Risk
203
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
23
num At Risk
369
group Id
EG001
num Affected
11
num At Risk
203
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
24
num At Risk
369
group Id
EG001
num Affected
12
num At Risk
203
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
71
num At Risk
369
group Id
EG001
num Affected
29
num At Risk
203
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
40
num At Risk
369
group Id
EG001
num Affected
23
num At Risk
203
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
42
num At Risk
369
group Id
EG001
num Affected
24
num At Risk
203
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
29
num At Risk
369
group Id
EG001
num Affected
16
num At Risk
203
term
Mucosal inflammation

Complete source fields

description

Safety Population.

event 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
EG000
other Num Affected
319
other Num At Risk
369
serious Num Affected
155
serious Num At Risk
369
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
EG001
other Num Affected
172
other Num At Risk
203
serious Num Affected
77
serious Num At Risk
203
title
Rituximab IV

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
104
num At Risk
369
group Id
EG001
num Affected
54
num At Risk
203
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
88
num At Risk
369
group Id
EG001
num Affected
40
num At Risk
203
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
79
num At Risk
369
group Id
EG001
num Affected
47
num At Risk
203
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
56
num At Risk
369
group Id
EG001
num Affected
34
num At Risk
203
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
52
num At Risk
369
group Id
EG001
num Affected
20
num At Risk
203
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
40
num At Risk
369
group Id
EG001
num Affected
17
num At Risk
203
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
23
num At Risk
369
group Id
EG001
num Affected
11
num At Risk
203
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
24
num At Risk
369
group Id
EG001
num Affected
12
num At Risk
203
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
71
num At Risk
369
group Id
EG001
num Affected
29
num At Risk
203
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
40
num At Risk
369
group Id
EG001
num Affected
23
num At Risk
203
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
42
num At Risk
369
group Id
EG001
num Affected
24
num At Risk
203
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
29
num At Risk
369
group Id
EG001
num Affected
16
num At Risk
203
term
Mucosal inflammation

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
49
num At Risk
369
group Id
EG001
num Affected
24
num At Risk
203
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
22
num At Risk
369
group Id
EG001
num Affected
10
num At Risk
203
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
2
num At Risk
369
group Id
EG001
num Affected
2
num At Risk
203
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
369
group Id
EG001
num Affected
3
num At Risk
203
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
0
num At Risk
369
group Id
EG001
num Affected
1
num At Risk
203
term
Febrile bone marrow aplasia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
369
group Id
EG001
num Affected
0
num At Risk
203
term
Pancytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
27
num At Risk
369
group Id
EG001
num Affected
7
num At Risk
203
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
3
num At Risk
369
group Id
EG001
num Affected
3
num At Risk
203
term
Septic shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
4
num At Risk
369
group Id
EG001
num Affected
1
num At Risk
203
term
Lung infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
2
num At Risk
369
group Id
EG001
num Affected
0
num At Risk
203
term
Respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
5
num At Risk
369
group Id
EG001
num Affected
0
num At Risk
203
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
2
num At Risk
369
group Id
EG001
num Affected
0
num At Risk
203
term
Cellulitis

time Frame

Up to approximately 4.25 years

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Preserved source evidence · Not medical advice