NCT03621982 · ADVERSE EVENTS

Adverse events

Study of ADCT-301 in Patients With Selected Advanced Solid Tumors · Source last updated 2024-06-13

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: All SAEs and AEs were collected from the time the participant signs the ICF until 30 days after the last dose of study drug up to a maximum of 3 years.
Other-event reporting threshold: 5%

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
ADCT-301 Monotherapy 20 µg/kg Part 1 (dose escalation): 20 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.	2 / 3	3 / 3	2 / 3
ADCT-301 Monotherapy 30 µg/kg Part 1 (dose escalation): 30 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.	1 / 5	5 / 5	4 / 5
ADCT-301 Monotherapy 45 µg/kg Part 1 (dose escalation): 45 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.	2 / 5	5 / 5	4 / 5
ADCT-301 Monotherapy 60 µg/kg Part 1 (dose escalation): 60 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.	3 / 5	5 / 5	3 / 5
ADCT-301 Monotherapy 80 µg/kg Part 1 (dose escalation): 80 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.	3 / 8	8 / 8	8 / 8
ADCT-301 Monotherapy 100 µg/kg Part 1 (dose escalation): 100 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.	1 / 7	7 / 7	4 / 7
ADCT-301 Monotherapy 125 µg/kg Part 1 (dose escalation): 125 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.	3 / 8	8 / 8	6 / 8
ADCT-301 Monotherapy 150 µg/kg Part 1 (dose escalation): 150 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.	3 / 3	3 / 3	3 / 3
ADCT-301 Combination Therapy 20 µg/kg + Pemb Participants received ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation) 20 µg/kg. Pembrolizumab at dose of 200 mg Q3W; IV was administered on Day 1 of each cycle starting from Cycle 1 onwards (dosing schedule 1).	1 / 1	1 / 1	0 / 1
ADCT-301 Combination Therapy 30 µg/kg + Pemb Participants received ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation) 30 µg/kg. Pembrolizumab at dose of 200 mg Q3W; IV was administered on Day 1 of each cycle starting from Cycle 1 onwards (dosing schedule 1).	3 / 4	4 / 4	3 / 4
ADCT Combination Therapy 45 µg/kg + Pemb Participants received ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation) 45 µg/kg. Pembrolizumab at dose of 200 mg Q3W; IV was administered on Day 1 of each cycle starting from Cycle 1 onwards (dosing schedule 1).	5 / 10	10 / 10	8 / 10
ADCT Combination Therapy 60 µg/kg + Pemb Participants received ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation) 60 µg/kg. Pembrolizumab at dose of 200 mg Q3W; IV was administered on Day 1 of each cycle starting from Cycle 1 onwards (dosing schedule 1).	8 / 9	9 / 9	4 / 9
ADCT Combination Therapy 80 µg/kg + Pemb Participants received ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation) 80 µg/kg. Pembrolizumab at dose of 200 mg Q3W; IV was administered on Day 1 of each cycle starting from Cycle 1 onwards (dosing schedule 1).	2 / 4	4 / 4	2 / 4
ADCT Combination Therapy 100 µg/kg + Pemb Participants received ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation) 100 µg/kg. Pembrolizumab at dose of 200 mg Q3W; IV was administered on Day 1 of each cycle starting from Cycle 1 onwards (dosing schedule 1).	5 / 6	6 / 6	2 / 6

Group identifiers: EG000: ADCT-301 Monotherapy 20 µg/kg · EG001: ADCT-301 Monotherapy 30 µg/kg · EG002: ADCT-301 Monotherapy 45 µg/kg · EG003: ADCT-301 Monotherapy 60 µg/kg · EG004: ADCT-301 Monotherapy 80 µg/kg · EG005: ADCT-301 Monotherapy 100 µg/kg · EG006: ADCT-301 Monotherapy 125 µg/kg · EG007: ADCT-301 Monotherapy 150 µg/kg · EG008: ADCT-301 Combination Therapy 20 µg/kg + Pemb · EG009: ADCT-301 Combination Therapy 30 µg/kg + Pemb · EG010: ADCT Combination Therapy 45 µg/kg + Pemb · EG011: ADCT Combination Therapy 60 µg/kg + Pemb · EG012: ADCT Combination Therapy 80 µg/kg + Pemb · EG013: ADCT Combination Therapy 100 µg/kg + Pemb

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
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
5
num Events
1
group Id
EG003
num Affected
1
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Duodenal ulcer haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
1
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Immune-mediated adverse reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
1
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Skin infection

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 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
2
num At Risk
5
num Events
4
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
2
num At Risk
7
num Events
2
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
4
num At Risk
10
num Events
5
group Id
EG011
num Affected
3
num At Risk
9
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
2
num At Risk
10
num Events
2
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
2
num At Risk
7
num Events
2
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
1
num At Risk
1
num Events
1
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Cerumen impaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Ear discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Vision blurred

Complete source fields

description

event Groups

deaths Num Affected
2
deaths Num At Risk
3
description
Part 1 (dose escalation): 20 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
ADCT-301 Monotherapy 20 µg/kg
deaths Num Affected
4
deaths Num At Risk
5
description
Part 1 (dose escalation): 30 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.
id
EG001
other Num Affected
5
other Num At Risk
5
serious Num Affected
1
serious Num At Risk
5
title
ADCT-301 Monotherapy 30 µg/kg
deaths Num Affected
4
deaths Num At Risk
5
description
Part 1 (dose escalation): 45 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.
id
EG002
other Num Affected
5
other Num At Risk
5
serious Num Affected
2
serious Num At Risk
5
title
ADCT-301 Monotherapy 45 µg/kg
deaths Num Affected
3
deaths Num At Risk
5
description
Part 1 (dose escalation): 60 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.
id
EG003
other Num Affected
5
other Num At Risk
5
serious Num Affected
3
serious Num At Risk
5
title
ADCT-301 Monotherapy 60 µg/kg
deaths Num Affected
8
deaths Num At Risk
8
description
Part 1 (dose escalation): 80 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.
id
EG004
other Num Affected
8
other Num At Risk
8
serious Num Affected
3
serious Num At Risk
8
title
ADCT-301 Monotherapy 80 µg/kg
deaths Num Affected
4
deaths Num At Risk
7
description
Part 1 (dose escalation): 100 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.
id
EG005
other Num Affected
7
other Num At Risk
7
serious Num Affected
1
serious Num At Risk
7
title
ADCT-301 Monotherapy 100 µg/kg
deaths Num Affected
6
deaths Num At Risk
8
description
Part 1 (dose escalation): 125 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.
id
EG006
other Num Affected
8
other Num At Risk
8
serious Num Affected
3
serious Num At Risk
8
title
ADCT-301 Monotherapy 125 µg/kg
deaths Num Affected
3
deaths Num At Risk
3
description
Part 1 (dose escalation): 150 μg/kg; Q3W; IV A treatment cycle was defined as 3 weeks (i.e., 21 days). Infusion on Day 1 of each cycle starting from Cycle 1 onwards.
id
EG007
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
ADCT-301 Monotherapy 150 µg/kg
deaths Num Affected
0
deaths Num At Risk
1
description
Participants received ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation) 20 µg/kg. Pembrolizumab at dose of 200 mg Q3W; IV was administered on Day 1 of each cycle starting from Cycle 1 onwards (dosing schedule 1).
id
EG008
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
ADCT-301 Combination Therapy 20 µg/kg + Pemb
deaths Num Affected
3
deaths Num At Risk
4
description
Participants received ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation) 30 µg/kg. Pembrolizumab at dose of 200 mg Q3W; IV was administered on Day 1 of each cycle starting from Cycle 1 onwards (dosing schedule 1).
id
EG009
other Num Affected
4
other Num At Risk
4
serious Num Affected
3
serious Num At Risk
4
title
ADCT-301 Combination Therapy 30 µg/kg + Pemb
deaths Num Affected
8
deaths Num At Risk
10
description
Participants received ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation) 45 µg/kg. Pembrolizumab at dose of 200 mg Q3W; IV was administered on Day 1 of each cycle starting from Cycle 1 onwards (dosing schedule 1).
id
EG010
other Num Affected
10
other Num At Risk
10
serious Num Affected
5
serious Num At Risk
10
title
ADCT Combination Therapy 45 µg/kg + Pemb
deaths Num Affected
4
deaths Num At Risk
9
description
Participants received ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation) 60 µg/kg. Pembrolizumab at dose of 200 mg Q3W; IV was administered on Day 1 of each cycle starting from Cycle 1 onwards (dosing schedule 1).
id
EG011
other Num Affected
9
other Num At Risk
9
serious Num Affected
8
serious Num At Risk
9
title
ADCT Combination Therapy 60 µg/kg + Pemb

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
2
num At Risk
5
num Events
4
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
2
num At Risk
7
num Events
2
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
4
num At Risk
10
num Events
5
group Id
EG011
num Affected
3
num At Risk
9
num Events
4
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
2
num At Risk
10
num Events
2
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
2
num At Risk
7
num Events
2
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
1
num At Risk
1
num Events
1
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Cerumen impaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Ear discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Vision blurred

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
5
num Events
1
group Id
EG003
num Affected
1
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Duodenal ulcer haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
num Events
0
group Id
EG004
num Affected
0
num At Risk
8
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
1
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Immune-mediated adverse reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
1
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
8
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
1
num At Risk
9
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
group Id
EG003
num Affected
0
num At Risk
5
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
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
8
num Events
1
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
1
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
10
num Events
0
group Id
EG011
num Affected
0
num At Risk
9
num Events
0
term
Skin infection

time Frame

All SAEs and AEs were collected from the time the participant signs the ICF until 30 days after the last dose of study drug up to a maximum of 3 years.

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Preserved source evidence · Not medical advice