NCT01812005 · ADVERSE EVENTS

Adverse events

Alisertib With and Without Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma · Source last updated 2018-06-06

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: 5%

The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort A Cohort A: Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	0 / 1	1 / 1	0 / 1
Cohort B Cohort B: Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	5 / 13	10 / 13	10 / 13

Group identifiers: EG000: Cohort A · EG001: Cohort B

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
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Duodenal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
2
num At Risk
13
num Events
2
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Generalized muscle weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Thromboembolic event
assessment Type
SYSTEMATIC_ASSESSMENT
notes
noninfective
organ System
Renal and urinary disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Cystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Hematuria

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
CTCAE version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
4
num At Risk
13
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
4
num At Risk
13
num Events
4
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Fatigue

Complete source fields

description

The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients

event Groups

deaths Num Affected
0
deaths Num At Risk
1
description
Cohort A: Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Cohort A
deaths Num Affected
10
deaths Num At Risk
13
description
Cohort B: Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
id
EG001
other Num Affected
10
other Num At Risk
13
serious Num Affected
5
serious Num At Risk
13
title
Cohort B

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
4
num At Risk
13
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
4
num At Risk
13
num Events
4
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
13
num Events
0
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Fatigue

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Duodenal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
2
num At Risk
13
num Events
2
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Generalized muscle weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Thromboembolic event
assessment Type
SYSTEMATIC_ASSESSMENT
notes
noninfective
organ System
Renal and urinary disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Cystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE version 4.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
13
num Events
1
term
Hematuria

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Preserved source evidence · Not medical advice