NCT01620216 · ADVERSE EVENTS

Adverse events

Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia · Source last updated 2021-11-04

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 event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.
Other-event reporting threshold: 5%

Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Group I (Dasatinib) Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Dasatinib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	2 / 4	3 / 4	0 / 4
Group II (Sunitinib Malate) Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Sunitinib: Given PO Sunitinib Malate: Given PO	0 / 2	0 / 2	0 / 2
Group III (Sorafenib Tosylate) Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Sorafenib: Given PO Sorafenib Tosylate: Given PO	5 / 6	6 / 6	0 / 6
Group IV (Ponatinib Hydrochloride) Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Ponatinib: Given PO Ponatinib Hydrochloride: Given PO	0 / 0	0 / 0	0 / 0
Group V (Pacritinib) Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pacritinib: Given PO Pharmacological Study: Correlative studies	0 / 0	0 / 0	0 / 0
Group VI (Ruxolitinib) Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Ruxolitinib: Given PO	0 / 0	0 / 0	0 / 0
Group VII (Idelalisib) Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Idelalisib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies	0 / 0	0 / 0	0 / 0

Group identifiers: EG000: Group I (Dasatinib) · EG001: Group II (Sunitinib Malate) · EG002: Group III (Sorafenib Tosylate) · EG003: Group IV (Ponatinib Hydrochloride) · EG004: Group V (Pacritinib) · EG005: Group VI (Ruxolitinib) · EG006: Group VII (Idelalisib)

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
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Myositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Tooth infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
4
num At Risk
6
num Events
5
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Hypoalbumenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
2
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Lipase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Respiratory failure

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
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Hyperleukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Bronchial infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Short of breath
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Troponemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Diarrhea

Complete source fields

description

Zero patients enrolled in Ponatinib, Pacritinib, Ruxolitinib, and Idealisib arms.

event Groups

deaths Num Affected
0
deaths Num At Risk
4
description
Patients receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Dasatinib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
id
EG000
other Num Affected
3
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Group I (Dasatinib)
deaths Num Affected
0
deaths Num At Risk
2
description
Patients receive sutinib malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Sunitinib: Given PO Sunitinib Malate: Given PO
id
EG001
other Num Affected
0
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Group II (Sunitinib Malate)
deaths Num Affected
0
deaths Num At Risk
6
description
Patients receive sorafenib tosylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Sorafenib: Given PO Sorafenib Tosylate: Given PO
id
EG002
other Num Affected
6
other Num At Risk
6
serious Num Affected
5
serious Num At Risk
6
title
Group III (Sorafenib Tosylate)
deaths Num Affected
0
deaths Num At Risk
0
description
Patients receive ponatinib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Ponatinib: Given PO Ponatinib Hydrochloride: Given PO
id
EG003
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Group IV (Ponatinib Hydrochloride)
deaths Num Affected
0
deaths Num At Risk
0
description
Patients receive pacritinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pacritinib: Given PO Pharmacological Study: Correlative studies
id
EG004
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Group V (Pacritinib)
deaths Num Affected
0
deaths Num At Risk
0
description
Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Ruxolitinib: Given PO
id
EG005
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Group VI (Ruxolitinib)
deaths Num Affected
0
deaths Num At Risk
0
description
Patients receive idelalisib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Antitumor Drug Screening Assay: Undergo pre clinical kinase inhibitor activity screening Idelalisib: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies
id
EG006
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Group VII (Idelalisib)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Hyperleukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Bronchial infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Short of breath
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Troponemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Diarrhea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
2
num At Risk
6
num Events
2
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Myositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Tooth infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
4
num At Risk
6
num Events
5
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Hypoalbumenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
2
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Lipase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num At Risk
0
group Id
EG004
num At Risk
0
group Id
EG005
num At Risk
0
group Id
EG006
num At Risk
0
term
Respiratory failure

time Frame

Adverse event collection began on the first day of the start of the induction chemotherapy and continued until 30 days post last dose of study drug.

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Preserved source evidence · Not medical advice