NCT00557193 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia · Source last updated 2024-07-15

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: Group 1: Study Entry to end-Induction (5 weeks). Other Groups: Start of Induction Intensification (Week 6) through 10 years post study enrollment.
Other-event reporting threshold: 0%

Adverse event reporting is collected routinely using case report forms. 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
Induction (All Patients) All Patients for Induction (not assigned)	9 / 210	181 / 210	6 / 210
Post Induction (Follow-up Only) Post-Induction patients that did not receive therapy	0 / 12	5 / 12	6 / 12
Arm A (Standard Risk MLL-G) Population Description: Eligible patients with MLL-G (germline, or non-rearranged) Asparaginase: Given IV, IM, or PO Cyclophosphamide: Given IV Cytarabine: Given IV or IT Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IV, IT, or PO Methylprednisolone: Given IV Pegaspargase: Given IM Pharmacological Study: Correlative studies Prednisone: Given PO Therapeutic Hydrocortisone: Given IT Vincristine Sulfate: Given IV	2 / 60	59 / 60	3 / 60
Arm B (IR/HR MLL-R Chemotherapy) Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \>= 90 days at diagnosis and High Risk (HR) if age \< 90 days at diagnosis. Asparaginase: Given IV, IM, or PO Cyclophosphamide: Given IV Cytarabine: Given IV or IT Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IV, IT, or PO Methylprednisolone: Given IV Pegaspargase: Given IM Pharmacological Study: Correlative studies Prednisone: Given PO Therapeutic Hydrocortisone: Given IT Vincristine Sulfate: Given IV	9 / 54	54 / 54	31 / 54
Arm C (Safety/ Dose Level 1) Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 1 (DL1) (HR: 3.5 mg/kg/day; SR: 4 mg/kg/day)	8 / 11	11 / 11	6 / 11
Arm C (Safety/ Dose Level 2) Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 2 (DL2) (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)	7 / 11	11 / 11	5 / 11
Arm C (Efficacy/ Dose Level 2) Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 2 (DL2)-Efficacy (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)	41 / 56	55 / 56	28 / 56

Group identifiers: EG000: Induction (All Patients) · EG001: Post Induction (Follow-up Only) · EG002: Arm A (Standard Risk MLL-G) · EG003: Arm B (IR/HR MLL-R Chemotherapy) · EG004: Arm C (Safety/ Dose Level 1) · EG005: Arm C (Safety/ Dose Level 2) · EG006: Arm C (Efficacy/ Dose Level 2)

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
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
1
num At Risk
11
num Events
1
group Id
EG006
num Affected
2
num At Risk
56
num Events
5
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
1
num At Risk
60
num Events
1
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
0
num At Risk
56
num Events
0
term
Blood and lymphatic system disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
6
num At Risk
11
num Events
7
group Id
EG005
num Affected
1
num At Risk
11
num Events
1
group Id
EG006
num Affected
22
num At Risk
56
num Events
42
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
1
num At Risk
56
num Events
1
term
Hemolytic uremic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
0
num At Risk
56
num Events
0
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
1
num At Risk
11
num Events
1
group Id
EG006
num Affected
1
num At Risk
56
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
1
num At Risk
56
num Events
1
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
2
num At Risk
56
num Events
2
term
Left ventricular systolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
1
num At Risk
56
num Events
1
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
2
num At Risk
56
num Events
3
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
1
num At Risk
11
num Events
1
group Id
EG006
num Affected
1
num At Risk
56
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
2
num At Risk
11
num Events
2
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
3
num At Risk
56
num Events
6
term
Colitis

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
CTCv4
stats
group Id
EG000
num Affected
4
num At Risk
210
num Events
4
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
4
num At Risk
60
num Events
7
group Id
EG003
num Affected
4
num At Risk
54
num Events
7
group Id
EG004
num Affected
1
num At Risk
11
num Events
2
group Id
EG005
num Affected
1
num At Risk
11
num Events
1
group Id
EG006
num Affected
5
num At Risk
56
num Events
7
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
0
num At Risk
56
num Events
0
term
Blood and lymphatic system disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
0
num At Risk
56
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
31
num At Risk
210
num Events
32
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
34
num At Risk
60
num Events
58
group Id
EG003
num Affected
32
num At Risk
54
num Events
69
group Id
EG004
num Affected
6
num At Risk
11
num Events
9
group Id
EG005
num Affected
4
num At Risk
11
num Events
13
group Id
EG006
num Affected
26
num At Risk
56
num Events
40
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
0
num At Risk
56
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
1
num At Risk
56
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
1
num At Risk
60
num Events
1
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
1
num At Risk
56
num Events
1
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
1
num At Risk
56
num Events
1
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
2
num At Risk
210
num Events
2
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
1
num At Risk
60
num Events
1
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
3
num At Risk
56
num Events
3
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
0
num At Risk
56
num Events
0
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
0
num At Risk
56
num Events
0
term
Eye disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
0
num At Risk
56
num Events
0
term
Abdominal distension

Complete source fields

description

event Groups

deaths Num Affected
6
deaths Num At Risk
210
description
All Patients for Induction (not assigned)
id
EG000
other Num Affected
181
other Num At Risk
210
serious Num Affected
9
serious Num At Risk
210
title
Induction (All Patients)
deaths Num Affected
6
deaths Num At Risk
12
description
Post-Induction patients that did not receive therapy
id
EG001
other Num Affected
5
other Num At Risk
12
serious Num Affected
0
serious Num At Risk
12
title
Post Induction (Follow-up Only)
deaths Num Affected
3
deaths Num At Risk
60
description
Population Description: Eligible patients with MLL-G (germline, or non-rearranged) Asparaginase: Given IV, IM, or PO Cyclophosphamide: Given IV Cytarabine: Given IV or IT Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IV, IT, or PO Methylprednisolone: Given IV Pegaspargase: Given IM Pharmacological Study: Correlative studies Prednisone: Given PO Therapeutic Hydrocortisone: Given IT Vincristine Sulfate: Given IV
id
EG002
other Num Affected
59
other Num At Risk
60
serious Num Affected
2
serious Num At Risk
60
title
Arm A (Standard Risk MLL-G)
deaths Num Affected
31
deaths Num At Risk
54
description
Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \>= 90 days at diagnosis and High Risk (HR) if age \< 90 days at diagnosis. Asparaginase: Given IV, IM, or PO Cyclophosphamide: Given IV Cytarabine: Given IV or IT Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IV, IT, or PO Methylprednisolone: Given IV Pegaspargase: Given IM Pharmacological Study: Correlative studies Prednisone: Given PO Therapeutic Hydrocortisone: Given IT Vincristine Sulfate: Given IV
id
EG003
other Num Affected
54
other Num At Risk
54
serious Num Affected
9
serious Num At Risk
54
title
Arm B (IR/HR MLL-R Chemotherapy)
deaths Num Affected
6
deaths Num At Risk
11
description
Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 1 (DL1) (HR: 3.5 mg/kg/day; SR: 4 mg/kg/day)
id
EG004
other Num Affected
11
other Num At Risk
11
serious Num Affected
8
serious Num At Risk
11
title
Arm C (Safety/ Dose Level 1)
deaths Num Affected
5
deaths Num At Risk
11
description
Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 2 (DL2) (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)
id
EG005
other Num Affected
11
other Num At Risk
11
serious Num Affected
7
serious Num At Risk
11
title
Arm C (Safety/ Dose Level 2)
deaths Num Affected
28
deaths Num At Risk
56
description
Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 2 (DL2)-Efficacy (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)
id
EG006
other Num Affected
55
other Num At Risk
56
serious Num Affected
41
serious Num At Risk
56
title
Arm C (Efficacy/ Dose Level 2)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
4
num At Risk
210
num Events
4
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
4
num At Risk
60
num Events
7
group Id
EG003
num Affected
4
num At Risk
54
num Events
7
group Id
EG004
num Affected
1
num At Risk
11
num Events
2
group Id
EG005
num Affected
1
num At Risk
11
num Events
1
group Id
EG006
num Affected
5
num At Risk
56
num Events
7
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
0
num At Risk
56
num Events
0
term
Blood and lymphatic system disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
0
num At Risk
56
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
31
num At Risk
210
num Events
32
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
34
num At Risk
60
num Events
58
group Id
EG003
num Affected
32
num At Risk
54
num Events
69
group Id
EG004
num Affected
6
num At Risk
11
num Events
9
group Id
EG005
num Affected
4
num At Risk
11
num Events
13
group Id
EG006
num Affected
26
num At Risk
56
num Events
40
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
0
num At Risk
56
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
1
num At Risk
56
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
1
num At Risk
60
num Events
1
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
1
num At Risk
56
num Events
1
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
1
num At Risk
56
num Events
1
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
2
num At Risk
210
num Events
2
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
1
num At Risk
60
num Events
1
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
3
num At Risk
56
num Events
3
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
0
num At Risk
56
num Events
0
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
0
num At Risk
56
num Events
0
term
Eye disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
0
num At Risk
56
num Events
0
term
Abdominal distension

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
1
num At Risk
11
num Events
1
group Id
EG006
num Affected
2
num At Risk
56
num Events
5
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
1
num At Risk
60
num Events
1
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
0
num At Risk
56
num Events
0
term
Blood and lymphatic system disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
6
num At Risk
11
num Events
7
group Id
EG005
num Affected
1
num At Risk
11
num Events
1
group Id
EG006
num Affected
22
num At Risk
56
num Events
42
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
1
num At Risk
56
num Events
1
term
Hemolytic uremic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
0
num At Risk
56
num Events
0
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
1
num At Risk
11
num Events
1
group Id
EG006
num Affected
1
num At Risk
56
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
1
num At Risk
56
num Events
1
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
1
num At Risk
11
num Events
1
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
2
num At Risk
56
num Events
2
term
Left ventricular systolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
1
num At Risk
56
num Events
1
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
2
num At Risk
56
num Events
3
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
1
num At Risk
54
num Events
1
group Id
EG004
num Affected
0
num At Risk
11
num Events
0
group Id
EG005
num Affected
1
num At Risk
11
num Events
1
group Id
EG006
num Affected
1
num At Risk
56
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
210
num Events
0
group Id
EG001
num Affected
0
num At Risk
12
num Events
0
group Id
EG002
num Affected
0
num At Risk
60
num Events
0
group Id
EG003
num Affected
0
num At Risk
54
num Events
0
group Id
EG004
num Affected
2
num At Risk
11
num Events
2
group Id
EG005
num Affected
0
num At Risk
11
num Events
0
group Id
EG006
num Affected
3
num At Risk
56
num Events
6
term
Colitis

time Frame

Group 1: Study Entry to end-Induction (5 weeks). Other Groups: Start of Induction Intensification (Week 6) through 10 years post study enrollment.

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

Preserved source evidence · Not medical advice