NCT01001442 · ADVERSE EVENTS

Adverse events

Safety and Dose Determining Multi-dose Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2019-07-30

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: Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
BT062 40 mg/m² 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	2 / 4	3 / 4	0 / 4
BT062 50 mg/m² 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	0 / 3	3 / 3	0 / 3
BT062 65 mg/m² 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	0 / 4	3 / 4	0 / 4
BT062 80 mg/m² 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	2 / 3	2 / 3	0 / 3
BT062 100 mg/m² 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	2 / 4	3 / 4	1 / 4
BT062 120 mg/m² 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	1 / 3	3 / 3	1 / 3
BT062 140 mg/m² 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	5 / 10	8 / 10	1 / 10
BT062 160 mg/m² 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.	2 / 4	3 / 4	1 / 4
Total BT062 administration (all dose levels)	14 / 35	28 / 35	4 / 35

Group identifiers: EG000: BT062 40 mg/m² · EG001: BT062 50 mg/m² · EG002: BT062 65 mg/m² · EG003: BT062 80 mg/m² · EG004: BT062 100 mg/m² · EG005: BT062 120 mg/m² · EG006: BT062 140 mg/m² · EG007: BT062 160 mg/m² · EG008: Total

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 (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
4
num Events
1
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
EXTRAOCULAR MUSCLE PARESIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
2
num At Risk
10
num Events
2
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
2
num At Risk
35
num Events
2
term
PYREXIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
2
num At Risk
10
num Events
2
group Id
EG007
num Affected
1
num At Risk
4
num Events
1
group Id
EG008
num Affected
3
num At Risk
35
num Events
3
term
PNEUMONIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
HEAD INJURY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
4
num Events
1
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
HIP FRACTURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
PELVIC FRACTURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
TRANSAMINASES INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
BONE PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
BRAIN MASS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
4
num Events
1
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
HAEMORRHAGE INTRACRANIAL

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 (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
2
group Id
EG004
num Affected
2
num At Risk
4
num Events
2
group Id
EG005
num Affected
1
num At Risk
3
num Events
2
group Id
EG006
num Affected
3
num At Risk
10
num Events
4
group Id
EG007
num Affected
1
num At Risk
4
num Events
1
group Id
EG008
num Affected
11
num At Risk
35
num Events
14
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
1
num At Risk
4
num Events
2
group Id
EG008
num Affected
3
num At Risk
35
num Events
4
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
5
num At Risk
35
num Events
5
term
LYMPHOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
1
num At Risk
4
num Events
2
group Id
EG008
num Affected
4
num At Risk
35
num Events
5
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
2
num At Risk
3
num Events
3
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
4
num At Risk
35
num Events
5
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
2
num At Risk
35
num Events
2
term
ABDOMINAL DISTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
1
num At Risk
4
num Events
1
group Id
EG008
num Affected
3
num At Risk
35
num Events
3
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
1
num At Risk
3
num Events
1
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
1
num At Risk
4
num Events
1
group Id
EG008
num Affected
5
num At Risk
35
num Events
5
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
3
group Id
EG002
num Affected
1
num At Risk
4
num Events
2
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
2
num At Risk
3
num Events
7
group Id
EG006
num Affected
3
num At Risk
10
num Events
3
group Id
EG007
num Affected
3
num At Risk
4
num Events
4
group Id
EG008
num Affected
13
num At Risk
35
num Events
21
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
2
num At Risk
35
num Events
2
term
DYSPEPSIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
2
num At Risk
35
num Events
2
term
HAEMATOCHEZIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
1
num At Risk
3
num Events
1
group Id
EG006
num Affected
3
num At Risk
10
num Events
4
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
8
num At Risk
35
num Events
9
term
NAUSEA

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
4
description
40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
id
EG000
other Num Affected
3
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
BT062 40 mg/m²
deaths Num Affected
0
deaths Num At Risk
3
description
50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
BT062 50 mg/m²
deaths Num Affected
0
deaths Num At Risk
4
description
65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
id
EG002
other Num Affected
3
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
BT062 65 mg/m²
deaths Num Affected
0
deaths Num At Risk
3
description
80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
id
EG003
other Num Affected
2
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
BT062 80 mg/m²
deaths Num Affected
1
deaths Num At Risk
4
description
100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
id
EG004
other Num Affected
3
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
BT062 100 mg/m²
deaths Num Affected
1
deaths Num At Risk
3
description
120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
id
EG005
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
BT062 120 mg/m²
deaths Num Affected
1
deaths Num At Risk
10
description
140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
id
EG006
other Num Affected
8
other Num At Risk
10
serious Num Affected
5
serious Num At Risk
10
title
BT062 140 mg/m²
deaths Num Affected
1
deaths Num At Risk
4
description
160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
id
EG007
other Num Affected
3
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
BT062 160 mg/m²
deaths Num Affected
4
deaths Num At Risk
35
description
BT062 administration (all dose levels)
id
EG008
other Num Affected
28
other Num At Risk
35
serious Num Affected
14
serious Num At Risk
35
title
Total

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
2
group Id
EG004
num Affected
2
num At Risk
4
num Events
2
group Id
EG005
num Affected
1
num At Risk
3
num Events
2
group Id
EG006
num Affected
3
num At Risk
10
num Events
4
group Id
EG007
num Affected
1
num At Risk
4
num Events
1
group Id
EG008
num Affected
11
num At Risk
35
num Events
14
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
1
num At Risk
4
num Events
2
group Id
EG008
num Affected
3
num At Risk
35
num Events
4
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
5
num At Risk
35
num Events
5
term
LYMPHOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
1
num At Risk
4
num Events
2
group Id
EG008
num Affected
4
num At Risk
35
num Events
5
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
2
num At Risk
3
num Events
3
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
4
num At Risk
35
num Events
5
term
THROMBOCYTOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
2
num At Risk
35
num Events
2
term
ABDOMINAL DISTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
1
num At Risk
4
num Events
1
group Id
EG008
num Affected
3
num At Risk
35
num Events
3
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
1
num At Risk
3
num Events
1
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
1
num At Risk
4
num Events
1
group Id
EG008
num Affected
5
num At Risk
35
num Events
5
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
3
group Id
EG002
num Affected
1
num At Risk
4
num Events
2
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
2
num At Risk
3
num Events
7
group Id
EG006
num Affected
3
num At Risk
10
num Events
3
group Id
EG007
num Affected
3
num At Risk
4
num Events
4
group Id
EG008
num Affected
13
num At Risk
35
num Events
21
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
2
num At Risk
35
num Events
2
term
DYSPEPSIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
2
num At Risk
35
num Events
2
term
HAEMATOCHEZIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
1
num At Risk
3
num Events
1
group Id
EG006
num Affected
3
num At Risk
10
num Events
4
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
8
num At Risk
35
num Events
9
term
NAUSEA

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
4
num Events
1
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
EXTRAOCULAR MUSCLE PARESIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
2
num At Risk
10
num Events
2
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
2
num At Risk
35
num Events
2
term
PYREXIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
2
num At Risk
10
num Events
2
group Id
EG007
num Affected
1
num At Risk
4
num Events
1
group Id
EG008
num Affected
3
num At Risk
35
num Events
3
term
PNEUMONIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
HEAD INJURY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
4
num Events
1
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
HIP FRACTURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
PELVIC FRACTURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
TRANSAMINASES INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
BONE PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
4
num Events
0
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
BRAIN MASS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
3
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
4
num Events
1
group Id
EG008
num Affected
1
num At Risk
35
num Events
1
term
HAEMORRHAGE INTRACRANIAL

time Frame

Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months).

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

Preserved source evidence · Not medical advice