NCT00372593 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia · Source last updated 2021-03-24

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%

SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.	26 / 511	482 / 511	Not reported / Not reported
Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.	32 / 511	479 / 511	Not reported / Not reported
Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.	2 / 6	5 / 6	Not reported / Not reported

Group identifiers: EG000: Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome · EG001: Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome · EG002: Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
3
num At Risk
511
group Id
EG001
num Affected
3
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Acidosis
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
8
num At Risk
511
group Id
EG001
num Affected
2
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Acute kidney injury
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
4
num At Risk
511
group Id
EG001
num Affected
8
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Adult respiratory distress syndrome
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
511
group Id
EG001
num Affected
2
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Alanine aminotransferase increased
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
511
group Id
EG001
num Affected
0
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Ascites
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
511
group Id
EG001
num Affected
2
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Aspartate aminotransferase increased
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
511
group Id
EG001
num Affected
1
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Atelectasis
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
511
group Id
EG001
num Affected
0
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Atrial flutter
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
511
group Id
EG001
num Affected
1
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Blood bilirubin increased
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
511
group Id
EG001
num Affected
1
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Bronchopulmonary hemorrhage
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
511
group Id
EG001
num Affected
1
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Bronchospasm
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
3
num At Risk
511
group Id
EG001
num Affected
4
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Cardiac disorders - Other

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
511
group Id
EG001
num Affected
4
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Abdominal distension
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
511
group Id
EG001
num Affected
1
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Abdominal infection
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
38
num At Risk
511
group Id
EG001
num Affected
44
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Abdominal pain
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
511
group Id
EG001
num Affected
2
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Abducens nerve disorder
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
7
num At Risk
511
group Id
EG001
num Affected
13
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Acidosis
organ System
Investigations
stats
group Id
EG000
num Affected
13
num At Risk
511
group Id
EG001
num Affected
15
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Activated partial thromboplastin time prolonged
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
9
num At Risk
511
group Id
EG001
num Affected
25
num At Risk
511
group Id
EG002
num Affected
1
num At Risk
6
term
Acute kidney injury
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
0
num At Risk
511
group Id
EG001
num Affected
2
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Adrenal insufficiency
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
21
num At Risk
511
group Id
EG001
num Affected
37
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Adult respiratory distress syndrome
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
2
num At Risk
511
group Id
EG001
num Affected
4
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Agitation
organ System
Investigations
stats
group Id
EG000
num Affected
84
num At Risk
511
group Id
EG001
num Affected
103
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Alanine aminotransferase increased
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
511
group Id
EG001
num Affected
2
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Alkaline phosphatase increased

Complete source fields

description

event Groups

description
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
id
EG000
other Num Affected
482
other Num At Risk
511
serious Num Affected
26
serious Num At Risk
511
title
Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome
description
Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
id
EG001
other Num Affected
479
other Num At Risk
511
serious Num Affected
32
serious Num At Risk
511
title
Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome
description
Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
id
EG002
other Num Affected
5
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome

frequency Threshold

other Events

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
511
group Id
EG001
num Affected
4
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Abdominal distension
organ System
Infections and infestations
stats
group Id
EG000
num Affected
2
num At Risk
511
group Id
EG001
num Affected
1
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Abdominal infection
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
38
num At Risk
511
group Id
EG001
num Affected
44
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Abdominal pain
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
511
group Id
EG001
num Affected
2
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Abducens nerve disorder
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
7
num At Risk
511
group Id
EG001
num Affected
13
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Acidosis
organ System
Investigations
stats
group Id
EG000
num Affected
13
num At Risk
511
group Id
EG001
num Affected
15
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Activated partial thromboplastin time prolonged
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
9
num At Risk
511
group Id
EG001
num Affected
25
num At Risk
511
group Id
EG002
num Affected
1
num At Risk
6
term
Acute kidney injury
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
0
num At Risk
511
group Id
EG001
num Affected
2
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Adrenal insufficiency
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
21
num At Risk
511
group Id
EG001
num Affected
37
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Adult respiratory distress syndrome
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
2
num At Risk
511
group Id
EG001
num Affected
4
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Agitation
organ System
Investigations
stats
group Id
EG000
num Affected
84
num At Risk
511
group Id
EG001
num Affected
103
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Alanine aminotransferase increased
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
511
group Id
EG001
num Affected
2
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Alkaline phosphatase increased

serious Events

organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
3
num At Risk
511
group Id
EG001
num Affected
3
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Acidosis
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
8
num At Risk
511
group Id
EG001
num Affected
2
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Acute kidney injury
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
4
num At Risk
511
group Id
EG001
num Affected
8
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Adult respiratory distress syndrome
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
511
group Id
EG001
num Affected
2
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Alanine aminotransferase increased
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
511
group Id
EG001
num Affected
0
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Ascites
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
511
group Id
EG001
num Affected
2
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Aspartate aminotransferase increased
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
511
group Id
EG001
num Affected
1
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Atelectasis
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
511
group Id
EG001
num Affected
0
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Atrial flutter
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
511
group Id
EG001
num Affected
1
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Blood bilirubin increased
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
511
group Id
EG001
num Affected
1
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Bronchopulmonary hemorrhage
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
511
group Id
EG001
num Affected
1
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Bronchospasm
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
3
num At Risk
511
group Id
EG001
num Affected
4
num At Risk
511
group Id
EG002
num Affected
0
num At Risk
6
term
Cardiac disorders - Other

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice