NCT01235793 · ADVERSE EVENTS

Adverse events

The Addition of Temozolomide to Conditioning for Autologous Transplantation in Relapsed & Refractory CNS Lymphoma · Source last updated 2018-11-20

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: Over a two year period, from start of research therapy to 2 years post treatment.
Other-event reporting threshold: 05%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
DRBEAT Regimen Temozolomide: The DRBEAT regimen will be similar to RBEAM. Rituximab and Carmustine will be given Day -6. Etoposide and Cytarabine will be given on Days -5 to -2. Temozolomide will be given via divided doses over five days starting on Day -5 to Day -1. A dose escalation design, known as EWOC (Escalation with overdose control) will be used to determine the target dose of temozolomide for this study. The starting dose given over five days will begin at 250mg/m\^2 (cumulative total dose of 1250 mg/m\^2), as previous data indicates this to be a safe dose. Based on the reported Dose Limiting toxicities from the previous patients, the EWOC statistical modeling will be performed to determine the next dose level.	6 / 11	11 / 11	6 / 11

Group identifiers: EG000: DRBEAT Regimen

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
notes
Temozolomide 431 mg/m\^2
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 351 mg/m\^2
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 431 mg/m\^2
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Gait disturbances
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 250 mg/m\^2
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Renal and Urinary disorders -Other, specify: High squamous epithelial cells
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 379 mg/m\^2, 611 mg/m\^2, and 762 mg/m\^2
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
11
num Events
3
term
Sepsis

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
notes
Temozolomide 351 mg/m\^2
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 351 mg/m\^2
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 734 mg/m\^2
organ System
Immune system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 379 mg/m\^2, 521 mg/m\^2, 611 mg/m\^2, 734 mg/m\^2, and 762 mg/m\^2
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
11
num Events
5
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 351 mg/m\^2
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 440 mg/m\^2
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Blood and lymphatic disorders -Other, specify: Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 351 mg/m\^2
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
2
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 379 mg/m\^2
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Facial muscle weakness
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 250 mg/m\^2 and 431 mg/m\^2
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
2
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 250 mg/m\^2 -1 participant, 287 mg/m\^2 -1 participant, 351 mg/m\^2 -1 participant (2 events), 379 mg/m\^2 -1 participant (2 events), 431 mg/m\^2 -1 participant, 521 mg/m\^2 -1 participant, 611 mg/m\^2 -1 participant, 693 mg/m\^2 -1 participant
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
9
num At Risk
11
num Events
11
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 734 mg/m\^2
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Hypertryglyceridemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 440 mg/m\^2
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Hyponatremia

Complete source fields

event Groups

deaths Num Affected
6
deaths Num At Risk
11
description
Temozolomide: The DRBEAT regimen will be similar to RBEAM. Rituximab and Carmustine will be given Day -6. Etoposide and Cytarabine will be given on Days -5 to -2. Temozolomide will be given via divided doses over five days starting on Day -5 to Day -1. A dose escalation design, known as EWOC (Escalation with overdose control) will be used to determine the target dose of temozolomide for this study. The starting dose given over five days will begin at 250mg/m\^2 (cumulative total dose of 1250 mg/m\^2), as previous data indicates this to be a safe dose. Based on the reported Dose Limiting toxicities from the previous patients, the EWOC statistical modeling will be performed to determine the next dose level.
id
EG000
other Num Affected
11
other Num At Risk
11
serious Num Affected
6
serious Num At Risk
11
title
DRBEAT Regimen

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 351 mg/m\^2
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 351 mg/m\^2
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 734 mg/m\^2
organ System
Immune system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 379 mg/m\^2, 521 mg/m\^2, 611 mg/m\^2, 734 mg/m\^2, and 762 mg/m\^2
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
11
num Events
5
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 351 mg/m\^2
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 440 mg/m\^2
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Blood and lymphatic disorders -Other, specify: Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 351 mg/m\^2
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
2
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 379 mg/m\^2
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Facial muscle weakness
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 250 mg/m\^2 and 431 mg/m\^2
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
2
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 250 mg/m\^2 -1 participant, 287 mg/m\^2 -1 participant, 351 mg/m\^2 -1 participant (2 events), 379 mg/m\^2 -1 participant (2 events), 431 mg/m\^2 -1 participant, 521 mg/m\^2 -1 participant, 611 mg/m\^2 -1 participant, 693 mg/m\^2 -1 participant
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
9
num At Risk
11
num Events
11
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 734 mg/m\^2
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Hypertryglyceridemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 440 mg/m\^2
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Hyponatremia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 431 mg/m\^2
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Encephalopathy
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 351 mg/m\^2
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 431 mg/m\^2
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Gait disturbances
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 250 mg/m\^2
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Renal and Urinary disorders -Other, specify: High squamous epithelial cells
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Temozolomide 379 mg/m\^2, 611 mg/m\^2, and 762 mg/m\^2
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
11
num Events
3
term
Sepsis

time Frame

Over a two year period, from start of research therapy to 2 years post treatment.

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Preserved source evidence · Not medical advice