NCT01200758 · ADVERSE EVENTS

Adverse events

A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma · Source last updated 2018-11-27

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: Baseline up to data cutoff date of 31 Oct 2017 (up to 6 years)
Other-event reporting threshold: 5%

Safety Analysis Population included all participants who received at least one dose of rituximab, either IV or SC. Safety Analysis Population included 6 participants who were randomized under Rituximab SC arm but withdrew after Cy1 and then analyzed under Rituximab IV arm.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.	76 / 210	187 / 210	Not reported / Not reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) First cycle of rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.	74 / 197	186 / 197	Not reported / Not reported

Group identifiers: EG000: Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) · EG001: Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)

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
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
7
num At Risk
210
group Id
EG001
num Affected
11
num At Risk
197
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
4
num At Risk
210
group Id
EG001
num Affected
1
num At Risk
197
term
Neutropenic sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
210
group Id
EG001
num Affected
2
num At Risk
197
term
Cystitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
2
num At Risk
210
group Id
EG001
num Affected
2
num At Risk
197
term
Lower respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
210
group Id
EG001
num Affected
2
num At Risk
197
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
2
num At Risk
210
group Id
EG001
num Affected
1
num At Risk
197
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
2
num At Risk
210
group Id
EG001
num Affected
0
num At Risk
197
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
210
group Id
EG001
num Affected
3
num At Risk
197
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
0
num At Risk
210
group Id
EG001
num Affected
1
num At Risk
197
term
Bacterial prostatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
0
num At Risk
210
group Id
EG001
num Affected
1
num At Risk
197
term
Creutzfeldt-Jakob disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
0
num At Risk
210
group Id
EG001
num Affected
1
num At Risk
197
term
Empyema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
210
group Id
EG001
num Affected
0
num At Risk
197
term
Gastroenteritis norovirus

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
Gastrointestinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
47
num At Risk
210
group Id
EG001
num Affected
65
num At Risk
197
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
55
num At Risk
210
group Id
EG001
num Affected
50
num At Risk
197
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
35
num At Risk
210
group Id
EG001
num Affected
34
num At Risk
197
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
27
num At Risk
210
group Id
EG001
num Affected
29
num At Risk
197
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
25
num At Risk
210
group Id
EG001
num Affected
29
num At Risk
197
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
14
num At Risk
210
group Id
EG001
num Affected
16
num At Risk
197
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
0
num At Risk
210
group Id
EG001
num Affected
27
num At Risk
197
term
Injection site erythema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
38
num At Risk
210
group Id
EG001
num Affected
42
num At Risk
197
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
27
num At Risk
210
group Id
EG001
num Affected
35
num At Risk
197
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
29
num At Risk
210
group Id
EG001
num Affected
29
num At Risk
197
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
18
num At Risk
210
group Id
EG001
num Affected
16
num At Risk
197
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
12
num At Risk
210
group Id
EG001
num Affected
9
num At Risk
197
term
Mucosal inflammation

Complete source fields

description

event Groups

description
Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.
id
EG000
other Num Affected
187
other Num At Risk
210
serious Num Affected
76
serious Num At Risk
210
title
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)
description
First cycle of rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
id
EG001
other Num Affected
186
other Num At Risk
197
serious Num Affected
74
serious Num At Risk
197
title
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
47
num At Risk
210
group Id
EG001
num Affected
65
num At Risk
197
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
55
num At Risk
210
group Id
EG001
num Affected
50
num At Risk
197
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
35
num At Risk
210
group Id
EG001
num Affected
34
num At Risk
197
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
27
num At Risk
210
group Id
EG001
num Affected
29
num At Risk
197
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
25
num At Risk
210
group Id
EG001
num Affected
29
num At Risk
197
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
14
num At Risk
210
group Id
EG001
num Affected
16
num At Risk
197
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
0
num At Risk
210
group Id
EG001
num Affected
27
num At Risk
197
term
Injection site erythema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
38
num At Risk
210
group Id
EG001
num Affected
42
num At Risk
197
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
27
num At Risk
210
group Id
EG001
num Affected
35
num At Risk
197
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
29
num At Risk
210
group Id
EG001
num Affected
29
num At Risk
197
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
18
num At Risk
210
group Id
EG001
num Affected
16
num At Risk
197
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
12
num At Risk
210
group Id
EG001
num Affected
9
num At Risk
197
term
Mucosal inflammation

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
7
num At Risk
210
group Id
EG001
num Affected
11
num At Risk
197
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
4
num At Risk
210
group Id
EG001
num Affected
1
num At Risk
197
term
Neutropenic sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
210
group Id
EG001
num Affected
2
num At Risk
197
term
Cystitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
2
num At Risk
210
group Id
EG001
num Affected
2
num At Risk
197
term
Lower respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
210
group Id
EG001
num Affected
2
num At Risk
197
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
2
num At Risk
210
group Id
EG001
num Affected
1
num At Risk
197
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
2
num At Risk
210
group Id
EG001
num Affected
0
num At Risk
197
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
210
group Id
EG001
num Affected
3
num At Risk
197
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
0
num At Risk
210
group Id
EG001
num Affected
1
num At Risk
197
term
Bacterial prostatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
0
num At Risk
210
group Id
EG001
num Affected
1
num At Risk
197
term
Creutzfeldt-Jakob disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
0
num At Risk
210
group Id
EG001
num Affected
1
num At Risk
197
term
Empyema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.1)
stats
group Id
EG000
num Affected
1
num At Risk
210
group Id
EG001
num Affected
0
num At Risk
197
term
Gastroenteritis norovirus

time Frame

Baseline up to data cutoff date of 31 Oct 2017 (up to 6 years)

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Preserved source evidence · Not medical advice