NCT01892371 · ADVERSE EVENTS

Adverse events

Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome · Source last updated 2025-04-06

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: Up to 9 years, 2 months
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1 Arm I (Quizartinib, Azacitidine) Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Quizartinib: Given PO	1 / 5	5 / 5	1 / 5
Phase 1 Arm II (Quizartinib, Cytarabine) Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cytarabine: Given SC Quizartinib: Given PO	0 / 1	1 / 1	0 / 1
Phase 2 Arm I (Quizartinib, Azacitidine) Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Quizartinib: Given PO	14 / 35	32 / 35	3 / 35
Phase 2 Arm II (Quizartinib, Cytarabine) Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cytarabine: Given SC	21 / 32	32 / 32	1 / 32

Group identifiers: EG000: Phase 1 Arm I (Quizartinib, Azacitidine) · EG001: Phase 1 Arm II (Quizartinib, Cytarabine) · EG002: Phase 2 Arm I (Quizartinib, Azacitidine) · EG003: Phase 2 Arm II (Quizartinib, Cytarabine)

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
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
1
num At Risk
32
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
term
Cardiac Arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
5
num At Risk
32
num Events
5
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
term
Failure to Thrive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
term
Fall
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
4
num At Risk
32
num Events
4
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
3
num At Risk
32
num Events
3
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
term
Gastric Hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
2
num At Risk
35
num Events
2
group Id
EG003
num Affected
4
num At Risk
32
num Events
5
term
Hypotension

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
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
term
Black Hairy Tongue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
5
num At Risk
32
num Events
5
term
Acute Kidney Injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
3
num At Risk
32
num Events
3
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
5
num Events
4
group Id
EG001
num Affected
1
num At Risk
1
num Events
1
group Id
EG002
num Affected
20
num At Risk
35
num Events
20
group Id
EG003
num Affected
11
num At Risk
32
num Events
11
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
2
num At Risk
32
num Events
2
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
1
num At Risk
1
num Events
1
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
term
Allergic Rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
1
num Events
1
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
4
num At Risk
32
num Events
4
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
1
num At Risk
1
num Events
1
group Id
EG002
num Affected
4
num At Risk
35
num Events
4
group Id
EG003
num Affected
6
num At Risk
32
num Events
6
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
2
num At Risk
35
num Events
2
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
5
num At Risk
35
num Events
7
group Id
EG003
num Affected
7
num At Risk
32
num Events
7
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
2
num At Risk
32
num Events
2
term
Atelectasis

Complete source fields

event Groups

deaths Num Affected
1
deaths Num At Risk
5
description
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Quizartinib: Given PO
id
EG000
other Num Affected
5
other Num At Risk
5
serious Num Affected
1
serious Num At Risk
5
title
Phase 1 Arm I (Quizartinib, Azacitidine)
deaths Num Affected
0
deaths Num At Risk
1
description
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cytarabine: Given SC Quizartinib: Given PO
id
EG001
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Phase 1 Arm II (Quizartinib, Cytarabine)
deaths Num Affected
3
deaths Num At Risk
35
description
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Quizartinib: Given PO
id
EG002
other Num Affected
32
other Num At Risk
35
serious Num Affected
14
serious Num At Risk
35
title
Phase 2 Arm I (Quizartinib, Azacitidine)
deaths Num Affected
1
deaths Num At Risk
32
description
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cytarabine: Given SC
id
EG003
other Num Affected
32
other Num At Risk
32
serious Num Affected
21
serious Num At Risk
32
title
Phase 2 Arm II (Quizartinib, Cytarabine)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
term
Black Hairy Tongue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
5
num At Risk
32
num Events
5
term
Acute Kidney Injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
3
num At Risk
32
num Events
3
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
5
num Events
4
group Id
EG001
num Affected
1
num At Risk
1
num Events
1
group Id
EG002
num Affected
20
num At Risk
35
num Events
20
group Id
EG003
num Affected
11
num At Risk
32
num Events
11
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
2
num At Risk
32
num Events
2
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
1
num At Risk
1
num Events
1
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
term
Allergic Rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
1
num Events
1
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
4
num At Risk
32
num Events
4
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
1
num At Risk
1
num Events
1
group Id
EG002
num Affected
4
num At Risk
35
num Events
4
group Id
EG003
num Affected
6
num At Risk
32
num Events
6
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
2
num At Risk
35
num Events
2
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
5
num At Risk
35
num Events
7
group Id
EG003
num Affected
7
num At Risk
32
num Events
7
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
2
num At Risk
32
num Events
2
term
Atelectasis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
1
num At Risk
32
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
term
Cardiac Arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
5
num At Risk
32
num Events
5
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
0
num At Risk
32
num Events
0
term
Failure to Thrive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
term
Fall
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
4
num At Risk
32
num Events
4
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
3
num At Risk
32
num Events
3
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
1
num At Risk
32
num Events
1
term
Gastric Hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
2
num At Risk
35
num Events
2
group Id
EG003
num Affected
4
num At Risk
32
num Events
5
term
Hypotension

time Frame

Up to 9 years, 2 months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice