NCT00651261 · ADVERSE EVENTS

Adverse events

Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia · Source last updated 2021-08-18

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: 0%

709 participants were evaluated for adverse events.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Induction and Consolidation Chemotherapy Plus Midostaurin Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.	157 / 355	321 / 355	Not reported / Not reported
Induction and Consolidation Chemotherapy Plus Placebo Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.	154 / 354	324 / 354	Not reported / Not reported

Group identifiers: EG000: Induction and Consolidation Chemotherapy Plus Midostaurin · EG001: Induction and Consolidation Chemotherapy Plus Placebo

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
355
num Events
0
group Id
EG001
num Affected
1
num At Risk
354
num Events
1
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
355
num Events
0
group Id
EG001
num Affected
1
num At Risk
354
num Events
1
term
Bone marrow hypocellular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
355
num Events
1
group Id
EG001
num Affected
0
num At Risk
354
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
105
num At Risk
355
num Events
144
group Id
EG001
num Affected
110
num At Risk
354
num Events
152
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
154
num At Risk
355
num Events
237
group Id
EG001
num Affected
148
num At Risk
354
num Events
230
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
355
num Events
2
group Id
EG001
num Affected
0
num At Risk
354
num Events
0
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
355
num Events
0
group Id
EG001
num Affected
1
num At Risk
354
num Events
1
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
6
num At Risk
355
num Events
6
group Id
EG001
num Affected
4
num At Risk
354
num Events
4
term
Lymphatic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
355
num Events
1
group Id
EG001
num Affected
2
num At Risk
354
num Events
2
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
355
num Events
1
group Id
EG001
num Affected
0
num At Risk
354
num Events
0
term
Asystole
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
4
num At Risk
355
num Events
4
group Id
EG001
num Affected
6
num At Risk
354
num Events
6
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
355
num Events
2
group Id
EG001
num Affected
2
num At Risk
354
num Events
2
term
Atrial flutter

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
MedDRA 6
stats
group Id
EG000
num Affected
5
num At Risk
355
num Events
11
group Id
EG001
num Affected
4
num At Risk
354
num Events
6
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
355
num Events
2
group Id
EG001
num Affected
1
num At Risk
354
num Events
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
246
num At Risk
355
num Events
422
group Id
EG001
num Affected
238
num At Risk
354
num Events
394
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
312
num At Risk
355
num Events
1059
group Id
EG001
num Affected
311
num At Risk
354
num Events
940
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
355
num Events
2
group Id
EG001
num Affected
0
num At Risk
354
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
10
num At Risk
355
num Events
13
group Id
EG001
num Affected
9
num At Risk
354
num Events
11
term
Lymphatic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
355
num Events
1
group Id
EG001
num Affected
4
num At Risk
354
num Events
4
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
3
num At Risk
355
num Events
3
group Id
EG001
num Affected
0
num At Risk
354
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
355
num Events
0
group Id
EG001
num Affected
1
num At Risk
354
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
355
num Events
3
group Id
EG001
num Affected
1
num At Risk
354
num Events
1
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
8
num At Risk
355
num Events
12
group Id
EG001
num Affected
13
num At Risk
354
num Events
17
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
4
num At Risk
355
num Events
6
group Id
EG001
num Affected
1
num At Risk
354
num Events
1
term
Cardiac pain

Complete source fields

description

709 participants were evaluated for adverse events.

event Groups

description
Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
id
EG000
other Num Affected
321
other Num At Risk
355
serious Num Affected
157
serious Num At Risk
355
title
Induction and Consolidation Chemotherapy Plus Midostaurin
description
Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
id
EG001
other Num Affected
324
other Num At Risk
354
serious Num Affected
154
serious Num At Risk
354
title
Induction and Consolidation Chemotherapy Plus Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
5
num At Risk
355
num Events
11
group Id
EG001
num Affected
4
num At Risk
354
num Events
6
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
355
num Events
2
group Id
EG001
num Affected
1
num At Risk
354
num Events
1
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
246
num At Risk
355
num Events
422
group Id
EG001
num Affected
238
num At Risk
354
num Events
394
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
312
num At Risk
355
num Events
1059
group Id
EG001
num Affected
311
num At Risk
354
num Events
940
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
355
num Events
2
group Id
EG001
num Affected
0
num At Risk
354
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
10
num At Risk
355
num Events
13
group Id
EG001
num Affected
9
num At Risk
354
num Events
11
term
Lymphatic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
355
num Events
1
group Id
EG001
num Affected
4
num At Risk
354
num Events
4
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
3
num At Risk
355
num Events
3
group Id
EG001
num Affected
0
num At Risk
354
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
355
num Events
0
group Id
EG001
num Affected
1
num At Risk
354
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
355
num Events
3
group Id
EG001
num Affected
1
num At Risk
354
num Events
1
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
8
num At Risk
355
num Events
12
group Id
EG001
num Affected
13
num At Risk
354
num Events
17
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
4
num At Risk
355
num Events
6
group Id
EG001
num Affected
1
num At Risk
354
num Events
1
term
Cardiac pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
355
num Events
0
group Id
EG001
num Affected
1
num At Risk
354
num Events
1
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
355
num Events
0
group Id
EG001
num Affected
1
num At Risk
354
num Events
1
term
Bone marrow hypocellular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
355
num Events
1
group Id
EG001
num Affected
0
num At Risk
354
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
105
num At Risk
355
num Events
144
group Id
EG001
num Affected
110
num At Risk
354
num Events
152
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
154
num At Risk
355
num Events
237
group Id
EG001
num Affected
148
num At Risk
354
num Events
230
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
355
num Events
2
group Id
EG001
num Affected
0
num At Risk
354
num Events
0
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
355
num Events
0
group Id
EG001
num Affected
1
num At Risk
354
num Events
1
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
6
num At Risk
355
num Events
6
group Id
EG001
num Affected
4
num At Risk
354
num Events
4
term
Lymphatic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
355
num Events
1
group Id
EG001
num Affected
2
num At Risk
354
num Events
2
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
355
num Events
1
group Id
EG001
num Affected
0
num At Risk
354
num Events
0
term
Asystole
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
4
num At Risk
355
num Events
4
group Id
EG001
num Affected
6
num At Risk
354
num Events
6
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
355
num Events
2
group Id
EG001
num Affected
2
num At Risk
354
num Events
2
term
Atrial flutter

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Preserved source evidence · Not medical advice