NCT01415882 · ADVERSE EVENTS

Adverse events

Ixazomib Citrate in Treating Patients With Relapsed Multiple Myeloma That Is Not Refractory to Bortezomib · Source last updated 2026-06-23

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: 2.5 years
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A (Ixazomib Citrate and Dexamethasone) Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	16 / 33	33 / 33	5 / 33
Arm B (Ixazomib Citrate and Dexamethasone) Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	11 / 35	35 / 35	5 / 35
Arm C (Higher-dose Ixazomib Citrate and Dexamethasone) Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	11 / 35	35 / 35	4 / 35
Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide) Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	14 / 36	36 / 36	8 / 36
Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab) Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	14 / 24	24 / 24	6 / 24

Group identifiers: EG000: Arm A (Ixazomib Citrate and Dexamethasone) · EG001: Arm B (Ixazomib Citrate and Dexamethasone) · EG002: Arm C (Higher-dose Ixazomib Citrate and Dexamethasone) · EG003: Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide) · EG004: Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)

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 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
3
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
1
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
1
num At Risk
35
num Events
1
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
1
num At Risk
36
num Events
1
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
1
num At Risk
35
num Events
1
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
1
num At Risk
36
num Events
1
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Vitreous hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
2
num At Risk
36
num Events
2
group Id
EG004
num Affected
2
num At Risk
24
num Events
2
term
Diarrhea

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 12
stats
group Id
EG000
num Affected
9
num At Risk
33
num Events
22
group Id
EG001
num Affected
6
num At Risk
35
num Events
59
group Id
EG002
num Affected
4
num At Risk
35
num Events
12
group Id
EG003
num Affected
16
num At Risk
36
num Events
237
group Id
EG004
num Affected
22
num At Risk
24
num Events
291
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
3
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Blood and lymph sys disorders - Oth Spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
1
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
1
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
1
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
1
num At Risk
24
num Events
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
1
num At Risk
24
num Events
12
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
3
group Id
EG003
num Affected
0
num At Risk
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Cushingoid
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
1
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
1
num At Risk
24
num Events
1
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
2
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
1
num At Risk
24
num Events
1
term
Eye disorders - Other, specify

Complete source fields

event Groups

deaths Num Affected
5
deaths Num At Risk
33
description
Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
33
other Num At Risk
33
serious Num Affected
16
serious Num At Risk
33
title
Arm A (Ixazomib Citrate and Dexamethasone)
deaths Num Affected
5
deaths Num At Risk
35
description
Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG001
other Num Affected
35
other Num At Risk
35
serious Num Affected
11
serious Num At Risk
35
title
Arm B (Ixazomib Citrate and Dexamethasone)
deaths Num Affected
4
deaths Num At Risk
35
description
Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG002
other Num Affected
35
other Num At Risk
35
serious Num Affected
11
serious Num At Risk
35
title
Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
deaths Num Affected
8
deaths Num At Risk
36
description
Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG003
other Num Affected
36
other Num At Risk
36
serious Num Affected
14
serious Num At Risk
36
title
Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
deaths Num Affected
6
deaths Num At Risk
24
description
Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG004
other Num Affected
24
other Num At Risk
24
serious Num Affected
14
serious Num At Risk
24
title
Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
9
num At Risk
33
num Events
22
group Id
EG001
num Affected
6
num At Risk
35
num Events
59
group Id
EG002
num Affected
4
num At Risk
35
num Events
12
group Id
EG003
num Affected
16
num At Risk
36
num Events
237
group Id
EG004
num Affected
22
num At Risk
24
num Events
291
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
3
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Blood and lymph sys disorders - Oth Spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
1
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
1
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
1
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
1
num At Risk
24
num Events
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
1
num At Risk
24
num Events
12
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
3
group Id
EG003
num Affected
0
num At Risk
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Cushingoid
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
1
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
1
num At Risk
24
num Events
1
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
2
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
1
num At Risk
24
num Events
1
term
Eye disorders - Other, specify

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
3
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
1
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
1
num At Risk
35
num Events
1
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
1
num At Risk
36
num Events
1
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
1
num At Risk
35
num Events
1
group Id
EG002
num Affected
0
num At Risk
35
num Events
0
group Id
EG003
num Affected
1
num At Risk
36
num Events
1
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
33
num Events
0
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Vitreous hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
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
36
num Events
0
group Id
EG004
num Affected
0
num At Risk
24
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
33
num Events
1
group Id
EG001
num Affected
0
num At Risk
35
num Events
0
group Id
EG002
num Affected
1
num At Risk
35
num Events
1
group Id
EG003
num Affected
2
num At Risk
36
num Events
2
group Id
EG004
num Affected
2
num At Risk
24
num Events
2
term
Diarrhea

time Frame

2.5 years

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

Preserved source evidence · Not medical advice