NCT00098774 · ADVERSE EVENTS

Adverse events

Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Primary CNS Lymphoma · Source last updated 2016-07-06

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Intensive Combination Chemo & Immunotherapy Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16 Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)	15 / 44	43 / 44	Not reported / Not reported

Group identifiers: EG000: Intensive Combination Chemo & Immunotherapy

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 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
11
num At Risk
44
num Events
13
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
44
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Cardiopulmonary arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Conduction disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
3
num At Risk
44
num Events
3
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Hearing impaired
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Keratitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
44
num Events
2
term
Abdominal pain

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
7
num At Risk
44
num Events
7
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
30
num At Risk
44
num Events
90
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
44
num Events
4
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
3
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
44
num Events
3
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
3
num At Risk
44
num Events
4
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Ear pain

Complete source fields

event Groups

description
Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16 Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)
id
EG000
other Num Affected
43
other Num At Risk
44
serious Num Affected
15
serious Num At Risk
44
title
Intensive Combination Chemo & Immunotherapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
7
num At Risk
44
num Events
7
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
30
num At Risk
44
num Events
90
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
44
num Events
4
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
3
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
44
num Events
3
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
3
num At Risk
44
num Events
4
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Ear pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
11
num At Risk
44
num Events
13
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
44
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Cardiopulmonary arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Conduction disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
3
num At Risk
44
num Events
3
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Hearing impaired
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Diplopia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Keratitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
44
num Events
1
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
44
num Events
2
term
Abdominal pain

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