NCT02312206 · ADVERSE EVENTS

Adverse events

The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis · Source last updated 2023-11-14

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: Initiation of study drug through the last study visit or up to 30 days after last dose, whichever is later
Other-event reporting threshold: 5%

AE that newly appears, increases in frequency, or worsens in severity following initiation of study drug and through the last study visit or up to 30 days after date of last dose, whichever is later up to 32 months

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
NEOD001 (24 mg/kg) + Standard of Care NEOD001, 24 mg/kg IV every 4 weeks on top of Standard of Care	88 / 130	124 / 130	41 / 130
Placebo + Standard of Care Placebo 0.9% Saline IV every 4 weeks on top of Standard of Care	91 / 130	125 / 130	42 / 130

Group identifiers: EG000: NEOD001 (24 mg/kg) + Standard of Care · EG001: Placebo + Standard of Care

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
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
17
num At Risk
130
group Id
EG001
num Affected
28
num At Risk
130
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
15
num At Risk
130
group Id
EG001
num Affected
9
num At Risk
130
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
9
num At Risk
130
group Id
EG001
num Affected
10
num At Risk
130
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
6
num At Risk
130
group Id
EG001
num Affected
6
num At Risk
130
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
5
num At Risk
130
group Id
EG001
num Affected
5
num At Risk
130
term
Cardiac failure acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
2
num At Risk
130
group Id
EG001
num Affected
5
num At Risk
130
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
3
num At Risk
130
group Id
EG001
num Affected
1
num At Risk
130
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
1
num At Risk
130
group Id
EG001
num Affected
1
num At Risk
130
term
Cardiogenic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
2
num At Risk
130
group Id
EG001
num Affected
0
num At Risk
130
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
2
num At Risk
130
group Id
EG001
num Affected
0
num At Risk
130
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
1
num At Risk
130
group Id
EG001
num Affected
1
num At Risk
130
term
Cardiac amyloidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
0
num At Risk
130
group Id
EG001
num Affected
1
num At Risk
130
term
Atrioventricular block

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
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
54
num At Risk
130
group Id
EG001
num Affected
55
num At Risk
130
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
51
num At Risk
130
group Id
EG001
num Affected
54
num At Risk
130
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
56
num At Risk
130
group Id
EG001
num Affected
43
num At Risk
130
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
25
num At Risk
130
group Id
EG001
num Affected
20
num At Risk
130
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
15
num At Risk
130
group Id
EG001
num Affected
15
num At Risk
130
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
14
num At Risk
130
group Id
EG001
num Affected
14
num At Risk
130
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
7
num At Risk
130
group Id
EG001
num Affected
8
num At Risk
130
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
6
num At Risk
130
group Id
EG001
num Affected
8
num At Risk
130
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
6
num At Risk
130
group Id
EG001
num Affected
7
num At Risk
130
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
7
num At Risk
130
group Id
EG001
num Affected
5
num At Risk
130
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
55
num At Risk
130
group Id
EG001
num Affected
56
num At Risk
130
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
57
num At Risk
130
group Id
EG001
num Affected
52
num At Risk
130
term
Fatigue

Complete source fields

description

event Groups

deaths Num Affected
41
deaths Num At Risk
130
description
NEOD001, 24 mg/kg IV every 4 weeks on top of Standard of Care
id
EG000
other Num Affected
124
other Num At Risk
130
serious Num Affected
88
serious Num At Risk
130
title
NEOD001 (24 mg/kg) + Standard of Care
deaths Num Affected
42
deaths Num At Risk
130
description
Placebo 0.9% Saline IV every 4 weeks on top of Standard of Care
id
EG001
other Num Affected
125
other Num At Risk
130
serious Num Affected
91
serious Num At Risk
130
title
Placebo + Standard of Care

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
54
num At Risk
130
group Id
EG001
num Affected
55
num At Risk
130
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
51
num At Risk
130
group Id
EG001
num Affected
54
num At Risk
130
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
56
num At Risk
130
group Id
EG001
num Affected
43
num At Risk
130
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
25
num At Risk
130
group Id
EG001
num Affected
20
num At Risk
130
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
15
num At Risk
130
group Id
EG001
num Affected
15
num At Risk
130
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
14
num At Risk
130
group Id
EG001
num Affected
14
num At Risk
130
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
7
num At Risk
130
group Id
EG001
num Affected
8
num At Risk
130
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
6
num At Risk
130
group Id
EG001
num Affected
8
num At Risk
130
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
6
num At Risk
130
group Id
EG001
num Affected
7
num At Risk
130
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
7
num At Risk
130
group Id
EG001
num Affected
5
num At Risk
130
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
55
num At Risk
130
group Id
EG001
num Affected
56
num At Risk
130
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
57
num At Risk
130
group Id
EG001
num Affected
52
num At Risk
130
term
Fatigue

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
17
num At Risk
130
group Id
EG001
num Affected
28
num At Risk
130
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
15
num At Risk
130
group Id
EG001
num Affected
9
num At Risk
130
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
9
num At Risk
130
group Id
EG001
num Affected
10
num At Risk
130
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
6
num At Risk
130
group Id
EG001
num Affected
6
num At Risk
130
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
5
num At Risk
130
group Id
EG001
num Affected
5
num At Risk
130
term
Cardiac failure acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
2
num At Risk
130
group Id
EG001
num Affected
5
num At Risk
130
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
3
num At Risk
130
group Id
EG001
num Affected
1
num At Risk
130
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
1
num At Risk
130
group Id
EG001
num Affected
1
num At Risk
130
term
Cardiogenic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
2
num At Risk
130
group Id
EG001
num Affected
0
num At Risk
130
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
2
num At Risk
130
group Id
EG001
num Affected
0
num At Risk
130
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
1
num At Risk
130
group Id
EG001
num Affected
1
num At Risk
130
term
Cardiac amyloidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA19.0 Hierarchy
stats
group Id
EG000
num Affected
0
num At Risk
130
group Id
EG001
num Affected
1
num At Risk
130
term
Atrioventricular block

time Frame

Initiation of study drug through the last study visit or up to 30 days after last dose, whichever is later

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Preserved source evidence · Not medical advice