NCT00722137 · ADVERSE EVENTS

Adverse events

Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma · Source last updated 2018-07-12

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 107.4 months
Other-event reporting threshold: 5%

The safety population was defined as all randomized participants who received at least 1 dose of study medication.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
R-CHOP Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, Vincristine 1.4 mg/m\^2 and Prednisone 100 mg/m\^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.	72 / 242	187 / 242	Not reported / Not reported
VcR-CAP Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, VELCADE 1.3 mg/m\^2, and Prednisone 100 mg/m\^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.	91 / 240	185 / 240	Not reported / Not reported

Group identifiers: EG000: R-CHOP · EG001: VcR-CAP

Serious adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
20
num At Risk
242
group Id
EG001
num Affected
26
num At Risk
240
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
13
num At Risk
242
group Id
EG001
num Affected
12
num At Risk
240
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
242
group Id
EG001
num Affected
8
num At Risk
240
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
3
num At Risk
242
group Id
EG001
num Affected
6
num At Risk
240
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
5
num At Risk
242
group Id
EG001
num Affected
4
num At Risk
240
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
242
group Id
EG001
num Affected
1
num At Risk
240
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
242
group Id
EG001
num Affected
1
num At Risk
240
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
7
num At Risk
242
group Id
EG001
num Affected
19
num At Risk
240
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
242
group Id
EG001
num Affected
4
num At Risk
240
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
2
num At Risk
242
group Id
EG001
num Affected
2
num At Risk
240
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
242
group Id
EG001
num Affected
2
num At Risk
240
term
Lobar pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
242
group Id
EG001
num Affected
2
num At Risk
240
term
Lung infection

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
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
33
num At Risk
242
group Id
EG001
num Affected
59
num At Risk
240
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
5
num At Risk
242
group Id
EG001
num Affected
22
num At Risk
240
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
9
num At Risk
242
group Id
EG001
num Affected
18
num At Risk
240
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
11
num At Risk
242
group Id
EG001
num Affected
16
num At Risk
240
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
14
num At Risk
242
group Id
EG001
num Affected
13
num At Risk
240
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
19
num At Risk
242
group Id
EG001
num Affected
19
num At Risk
240
term
Neuropathy peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
12
num At Risk
242
group Id
EG001
num Affected
16
num At Risk
240
term
Paraesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
9
num At Risk
242
group Id
EG001
num Affected
15
num At Risk
240
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
15
num At Risk
242
group Id
EG001
num Affected
15
num At Risk
240
term
Hypoaesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
11
num At Risk
242
group Id
EG001
num Affected
13
num At Risk
240
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
20
num At Risk
242
group Id
EG001
num Affected
49
num At Risk
240
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
10
num At Risk
242
group Id
EG001
num Affected
14
num At Risk
240
term
Oropharyngeal pain

Complete source fields

description

The safety population was defined as all randomized participants who received at least 1 dose of study medication.

event Groups

description
Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, Vincristine 1.4 mg/m\^2 and Prednisone 100 mg/m\^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
id
EG000
other Num Affected
187
other Num At Risk
242
serious Num Affected
72
serious Num At Risk
242
title
R-CHOP
description
Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, VELCADE 1.3 mg/m\^2, and Prednisone 100 mg/m\^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
id
EG001
other Num Affected
185
other Num At Risk
240
serious Num Affected
91
serious Num At Risk
240
title
VcR-CAP

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
33
num At Risk
242
group Id
EG001
num Affected
59
num At Risk
240
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
5
num At Risk
242
group Id
EG001
num Affected
22
num At Risk
240
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
9
num At Risk
242
group Id
EG001
num Affected
18
num At Risk
240
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
11
num At Risk
242
group Id
EG001
num Affected
16
num At Risk
240
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
14
num At Risk
242
group Id
EG001
num Affected
13
num At Risk
240
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
19
num At Risk
242
group Id
EG001
num Affected
19
num At Risk
240
term
Neuropathy peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
12
num At Risk
242
group Id
EG001
num Affected
16
num At Risk
240
term
Paraesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
9
num At Risk
242
group Id
EG001
num Affected
15
num At Risk
240
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
15
num At Risk
242
group Id
EG001
num Affected
15
num At Risk
240
term
Hypoaesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
11
num At Risk
242
group Id
EG001
num Affected
13
num At Risk
240
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
20
num At Risk
242
group Id
EG001
num Affected
49
num At Risk
240
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
10
num At Risk
242
group Id
EG001
num Affected
14
num At Risk
240
term
Oropharyngeal pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
20
num At Risk
242
group Id
EG001
num Affected
26
num At Risk
240
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
13
num At Risk
242
group Id
EG001
num Affected
12
num At Risk
240
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
242
group Id
EG001
num Affected
8
num At Risk
240
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
3
num At Risk
242
group Id
EG001
num Affected
6
num At Risk
240
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
5
num At Risk
242
group Id
EG001
num Affected
4
num At Risk
240
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
242
group Id
EG001
num Affected
1
num At Risk
240
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
242
group Id
EG001
num Affected
1
num At Risk
240
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
7
num At Risk
242
group Id
EG001
num Affected
19
num At Risk
240
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
242
group Id
EG001
num Affected
4
num At Risk
240
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
2
num At Risk
242
group Id
EG001
num Affected
2
num At Risk
240
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
242
group Id
EG001
num Affected
2
num At Risk
240
term
Lobar pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
242
group Id
EG001
num Affected
2
num At Risk
240
term
Lung infection

time Frame

Up to 107.4 months

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Preserved source evidence · Not medical advice