NCT03345485 · ADVERSE EVENTS

Adverse events

Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors. · Source last updated 2024-10-21

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: Phase (P) 1: From time of first dose to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation/resolution (up to 33 months). P2 and Substudies (SS): From point of ICF signature to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation or resolution (P2 and SS1 -up to 49 months) or (SS2 up to 18 months).
Other-event reporting threshold: 0%

TEAE will be captured from the first day of study drug dosing through discontinuation of study drug (at any time or Day 28 of the last treatment cycle). Serious adverse events (SAEs) will be reported from first day of study drug until 30 days after last treatment. P1: All AEs were coded using the MedDRA® version 24.0 and P2 using the MedDRA® version 20.0.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1 Patients who received 60mg/m2 over 30 minutes infusion time of EDO-S101	1 / 3	3 / 3	0 / 3
Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2 Patients who received 80mg/m2 over 30 minutes infusion time of EDO-S101	2 / 3	3 / 3	0 / 3
Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3 Patients who received 100mg/m2 over 30 minutes infusion time of EDO-S101	2 / 3	3 / 3	1 / 3
Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4 Patients who received 60mg/m2 over 60 minutes infusion time of EDO-S101	3 / 3	3 / 3	0 / 3
Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5 Patients who received who 80mg/m2 over 60 minutes infusion time of EDO-S101	5 / 8	8 / 8	2 / 8
Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6 Patients who received who 100mg/m2 over 60 minutes infusion time of EDO-S101	2 / 2	2 / 2	0 / 2
Tinostamustine (EDO-S101) - Phase 2 SCLC Patient with relapsed/refractory SCLC who received 80mg/m2 over 60 minutes infusion time of EDO-S101	0 / 4	4 / 4	1 / 4
Tinostamustine (EDO-S101) - Phase 2 STS Patient with relapsed/refractory STS who received 80mg/m2 over 60 minutes infusion time of EDO-S101	6 / 10	10 / 10	3 / 10
Tinostamustine (EDO-S101) - Phase 2 TNBC Patient with relapsed/refractory TNBC who received 80mg/m2 over 60 minutes infusion time of EDO-S101	1 / 4	4 / 4	2 / 4
Tinostamustine (EDO-S101) - Phase 2 OC Patient with relapsed/refractory OC who received 80mg/m2 over 60 minutes infusion time of EDO-S101	7 / 12	12 / 12	2 / 12
Tinostamustine (EDO-S101) - Phase 2 EC Patient with relapsed/refractory EC who received 80mg/m2 over 60 minutes infusion time of EDO-S101	4 / 6	6 / 6	3 / 6
Tinostamustine (EDO-S101) - Sub Study (SS1) Patients who received 60mg/m2 over 60 minutes infusion time of EDO-S101	6 / 6	6 / 6	4 / 6
Tinostamustine (EDO-S101) - Sub Study 2 (SS2) Patients who received 80mg/m2 over 80 minutes infusion time of EDO-S101	0 / 7	6 / 7	2 / 7

Group identifiers: EG000: Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1 · EG001: Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2 · EG002: Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3 · EG003: Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4 · EG004: Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5 · EG005: Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6 · EG006: Tinostamustine (EDO-S101) - Phase 2 SCLC · EG007: Tinostamustine (EDO-S101) - Phase 2 STS · EG008: Tinostamustine (EDO-S101) - Phase 2 TNBC · EG009: Tinostamustine (EDO-S101) - Phase 2 OC · EG010: Tinostamustine (EDO-S101) - Phase 2 EC · EG011: Tinostamustine (EDO-S101) - Sub Study (SS1) · EG012: Tinostamustine (EDO-S101) - Sub Study 2 (SS2)

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 (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
12
num Events
1
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
1
num At Risk
6
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
12
num Events
1
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
1
num At Risk
6
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Acute Myocardial Infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
1
num At Risk
6
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Coronary Artery Thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
12
num Events
1
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Fistula of small intestine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Haemorrhagic ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Intestinal Perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
12
num Events
1
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Intra-abdominal haemorrhage

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 (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
4
group Id
EG001
num Affected
3
num At Risk
3
num Events
7
group Id
EG002
num Affected
3
num At Risk
3
num Events
6
group Id
EG003
num Affected
3
num At Risk
3
num Events
16
group Id
EG004
num Affected
3
num At Risk
8
num Events
6
group Id
EG005
num Affected
1
num At Risk
2
num Events
1
group Id
EG006
num Affected
1
num At Risk
4
num Events
1
group Id
EG007
num Affected
2
num At Risk
10
num Events
4
group Id
EG008
num Affected
2
num At Risk
4
num Events
3
group Id
EG009
num Affected
5
num At Risk
12
num Events
7
group Id
EG010
num Affected
4
num At Risk
6
num Events
15
group Id
EG011
num Affected
2
num At Risk
6
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
1
num At Risk
6
num Events
1
term
Cyclic neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
1
num At Risk
4
num Events
1
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Hypereosinophilic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
2
num At Risk
12
num Events
2
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
12
num Events
4
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
12
num Events
2
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
1
num At Risk
6
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Otorrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Conjunctival haemorrhage

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
Patients who received 60mg/m2 over 30 minutes infusion time of EDO-S101
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1
deaths Num Affected
0
deaths Num At Risk
3
description
Patients who received 80mg/m2 over 30 minutes infusion time of EDO-S101
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2
deaths Num Affected
1
deaths Num At Risk
3
description
Patients who received 100mg/m2 over 30 minutes infusion time of EDO-S101
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3
deaths Num Affected
0
deaths Num At Risk
3
description
Patients who received 60mg/m2 over 60 minutes infusion time of EDO-S101
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4
deaths Num Affected
2
deaths Num At Risk
8
description
Patients who received who 80mg/m2 over 60 minutes infusion time of EDO-S101
id
EG004
other Num Affected
8
other Num At Risk
8
serious Num Affected
5
serious Num At Risk
8
title
Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5
deaths Num Affected
0
deaths Num At Risk
2
description
Patients who received who 100mg/m2 over 60 minutes infusion time of EDO-S101
id
EG005
other Num Affected
2
other Num At Risk
2
serious Num Affected
2
serious Num At Risk
2
title
Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6
deaths Num Affected
1
deaths Num At Risk
4
description
Patient with relapsed/refractory SCLC who received 80mg/m2 over 60 minutes infusion time of EDO-S101
id
EG006
other Num Affected
4
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
Tinostamustine (EDO-S101) - Phase 2 SCLC
deaths Num Affected
3
deaths Num At Risk
10
description
Patient with relapsed/refractory STS who received 80mg/m2 over 60 minutes infusion time of EDO-S101
id
EG007
other Num Affected
10
other Num At Risk
10
serious Num Affected
6
serious Num At Risk
10
title
Tinostamustine (EDO-S101) - Phase 2 STS
deaths Num Affected
2
deaths Num At Risk
4
description
Patient with relapsed/refractory TNBC who received 80mg/m2 over 60 minutes infusion time of EDO-S101
id
EG008
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Tinostamustine (EDO-S101) - Phase 2 TNBC
deaths Num Affected
2
deaths Num At Risk
12
description
Patient with relapsed/refractory OC who received 80mg/m2 over 60 minutes infusion time of EDO-S101
id
EG009
other Num Affected
12
other Num At Risk
12
serious Num Affected
7
serious Num At Risk
12
title
Tinostamustine (EDO-S101) - Phase 2 OC
deaths Num Affected
3
deaths Num At Risk
6
description
Patient with relapsed/refractory EC who received 80mg/m2 over 60 minutes infusion time of EDO-S101
id
EG010
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
Tinostamustine (EDO-S101) - Phase 2 EC
deaths Num Affected
4
deaths Num At Risk
6
description
Patients who received 60mg/m2 over 60 minutes infusion time of EDO-S101
id
EG011
other Num Affected
6
other Num At Risk
6
serious Num Affected
6
serious Num At Risk
6
title
Tinostamustine (EDO-S101) - Sub Study (SS1)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
4
group Id
EG001
num Affected
3
num At Risk
3
num Events
7
group Id
EG002
num Affected
3
num At Risk
3
num Events
6
group Id
EG003
num Affected
3
num At Risk
3
num Events
16
group Id
EG004
num Affected
3
num At Risk
8
num Events
6
group Id
EG005
num Affected
1
num At Risk
2
num Events
1
group Id
EG006
num Affected
1
num At Risk
4
num Events
1
group Id
EG007
num Affected
2
num At Risk
10
num Events
4
group Id
EG008
num Affected
2
num At Risk
4
num Events
3
group Id
EG009
num Affected
5
num At Risk
12
num Events
7
group Id
EG010
num Affected
4
num At Risk
6
num Events
15
group Id
EG011
num Affected
2
num At Risk
6
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
1
num At Risk
6
num Events
1
term
Cyclic neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
1
num At Risk
4
num Events
1
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Hypereosinophilic syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
2
num At Risk
12
num Events
2
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
12
num Events
4
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
12
num Events
2
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
1
num At Risk
6
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Otorrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Conjunctival haemorrhage

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
12
num Events
1
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
1
num At Risk
6
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
1
num At Risk
10
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
12
num Events
1
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
1
num At Risk
6
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Acute Myocardial Infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
1
num At Risk
6
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Coronary Artery Thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
1
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
12
num Events
1
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Fistula of small intestine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Haemorrhagic ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
12
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Intestinal Perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
3
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
3
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
8
num Events
0
group Id
EG005
num Affected
0
num At Risk
2
num Events
0
group Id
EG006
num Affected
0
num At Risk
4
num Events
0
group Id
EG007
num Affected
0
num At Risk
10
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
1
num At Risk
12
num Events
1
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
6
num Events
0
term
Intra-abdominal haemorrhage

time Frame

Phase (P) 1: From time of first dose to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation/resolution (up to 33 months). P2 and Substudies (SS): From point of ICF signature to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation or resolution (P2 and SS1 -up to 49 months) or (SS2 up to 18 months).

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Preserved source evidence · Not medical advice