NCT02113007 · ADVERSE EVENTS

Adverse events

Study of High-Dose Rituximab With Temozolomide as Treatment for Primary Central Nervous System (CNS) Lymphoma · Source last updated 2017-02-07

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: Adverse events and serious adverse events were collected for up to 4 weeks during the safety lead-in part of the study. The study closed early due to slow accrual.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Rituximab Plus Temozolomide Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5 Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles.	1 / 2	2 / 2	Not reported / Not reported

Group identifiers: EG000: Rituximab Plus Temozolomide

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
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Hyponatraemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Hypoglycemia

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
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
2
term
Flatulence
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
2
term
Hypersomnia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
2
term
Hypoalbuminemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
2
term
Gait disturbance
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
2
num At Risk
2
term
Fatigue

Complete source fields

event Groups

description
Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5 Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles.
id
EG000
other Num Affected
2
other Num At Risk
2
serious Num Affected
1
serious Num At Risk
2
title
Rituximab Plus Temozolomide

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
2
term
Flatulence
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
2
term
Hypersomnia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
2
term
Hypoalbuminemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
2
term
Gait disturbance
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
2
num At Risk
2
term
Fatigue

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Hyponatraemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Hypoglycemia

time Frame

Adverse events and serious adverse events were collected for up to 4 weeks during the safety lead-in part of the study. The study closed early due to slow accrual.

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Preserved source evidence · Not medical advice