NCT00267865 · ADVERSE EVENTS

Adverse events

Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma · Source last updated 2020-06-01

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: Date treatment consent signed to date off study, approximately 142 months and 11 days.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Rituximab, High-Dose Methotrexate & Leucovorin Treatment Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy. Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour. Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes	3 / 12	11 / 12	3 / 12

Group identifiers: EG000: Rituximab, High-Dose Methotrexate & Leucovorin Treatment

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
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
Death not associated with CTCAE term::Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
Death not associated with CTCAE term::Disease progression NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
Hemorrhage, GI::Upper GI NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
Pulmonary/Upper Respiratory - Other (Specify, Patient intubated)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
Pulmonary/Upper Respiratory - Other (Specify, Pulmonary embolism)

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
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
9
num At Risk
12
num Events
58
term
ALT, SGPT (serum glutamic pyruvic transaminase)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
11
num At Risk
12
num Events
64
term
AST, SGOT(serum glutamic oxaloacetic transaminase)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
10
num At Risk
12
num Events
72
term
Albumin, serum-low (hypoalbuminemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
6
num At Risk
12
num Events
39
term
Alkaline phosphatase
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
Alkalosis (metabolic or respiratory)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
3
term
Ataxia (incoordination)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
12
term
Bilirubin (hyperbilirubinemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
2
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
12
num Events
19
term
CD4 count
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
4
term
CPK (creatine phosphokinase)

Complete source fields

event Groups

deaths Num Affected
3
deaths Num At Risk
12
description
Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy. Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour. Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
id
EG000
other Num Affected
11
other Num At Risk
12
serious Num Affected
3
serious Num At Risk
12
title
Rituximab, High-Dose Methotrexate & Leucovorin Treatment

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
9
num At Risk
12
num Events
58
term
ALT, SGPT (serum glutamic pyruvic transaminase)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
11
num At Risk
12
num Events
64
term
AST, SGOT(serum glutamic oxaloacetic transaminase)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
10
num At Risk
12
num Events
72
term
Albumin, serum-low (hypoalbuminemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
6
num At Risk
12
num Events
39
term
Alkaline phosphatase
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
Alkalosis (metabolic or respiratory)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
3
term
Ataxia (incoordination)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
12
term
Bilirubin (hyperbilirubinemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
2
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
12
num Events
19
term
CD4 count
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
4
term
CPK (creatine phosphokinase)

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
Death not associated with CTCAE term::Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
Death not associated with CTCAE term::Disease progression NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
Hemorrhage, GI::Upper GI NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
Pulmonary/Upper Respiratory - Other (Specify, Patient intubated)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
term
Pulmonary/Upper Respiratory - Other (Specify, Pulmonary embolism)

time Frame

Date treatment consent signed to date off study, approximately 142 months and 11 days.

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Preserved source evidence · Not medical advice