NCT01049945 · ADVERSE EVENTS

Adverse events

Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma · Source last updated 2020-02-11

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%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase I, Dose Level 1 Bendamustine 50 mg/m\^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity	0 / 3	3 / 3	Not reported / Not reported
Phase I, Dose Level 2 Bendamustine 50 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity	2 / 6	6 / 6	Not reported / Not reported
Phase I, Dose Level 3 Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity	2 / 3	3 / 3	Not reported / Not reported
Phase I, Dose Level 4 Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity	2 / 6	6 / 6	Not reported / Not reported
Phase I, Dose Level 5 Bendamustine 100 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity	1 / 3	3 / 3	Not reported / Not reported
Phase II, Dose Level 4 Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity	24 / 49	49 / 49	Not reported / Not reported

Group identifiers: EG000: Phase I, Dose Level 1 · EG001: Phase I, Dose Level 2 · EG002: Phase I, Dose Level 3 · EG003: Phase I, Dose Level 4 · EG004: Phase I, Dose Level 5 · EG005: Phase II, Dose Level 4

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
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Herpes Zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
2
num At Risk
49
num Events
2
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
2
num At Risk
49
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
49
num Events
0
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
3
num At Risk
49
num Events
3
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Fatigue

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
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
7
num At Risk
49
num Events
8
term
Herpes Zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
3
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
8
num At Risk
49
num Events
14
term
Leg Cramp
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
22
num At Risk
49
num Events
25
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Cardiac pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Conduction disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
2
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
5
num At Risk
49
num Events
5
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
4
num At Risk
49
num Events
4
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
49
num Events
0
term
Ventricular arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Hypothyroidism

Complete source fields

event Groups

description
Bendamustine 50 mg/m\^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Phase I, Dose Level 1
description
Bendamustine 50 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Phase I, Dose Level 2
description
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Phase I, Dose Level 3
description
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
id
EG003
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Phase I, Dose Level 4
description
Bendamustine 100 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
id
EG004
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Phase I, Dose Level 5
description
Bendamustine 75 mg/m\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
id
EG005
other Num Affected
49
other Num At Risk
49
serious Num Affected
24
serious Num At Risk
49
title
Phase II, Dose Level 4

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
7
num At Risk
49
num Events
8
term
Herpes Zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
3
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
8
num At Risk
49
num Events
14
term
Leg Cramp
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
22
num At Risk
49
num Events
25
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Cardiac pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Conduction disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
2
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
5
num At Risk
49
num Events
5
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
4
num At Risk
49
num Events
4
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
49
num Events
0
term
Ventricular arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Hypothyroidism

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Herpes Zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
2
num At Risk
49
num Events
2
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
2
num At Risk
49
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
49
num Events
0
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
3
num At Risk
49
num Events
3
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
49
num Events
1
term
Fatigue

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Preserved source evidence · Not medical advice