NCT03215030 · ADVERSE EVENTS

Adverse events

A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma · Source last updated 2026-01-29

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: Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in
Other-event reporting threshold: 5%

The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part 1 (Dose Escalation) Schedule A Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.	8 / 20	20 / 20	15 / 20
Part 1 (Dose Escalation) Schedule B Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.	6 / 8	8 / 8	6 / 8
Part 1 (Dose Escalation) Schedule C Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.	2 / 7	7 / 7	6 / 7
Part 1 (Dose Escalation) Schedule D Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.	13 / 21	21 / 21	8 / 21
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.	1 / 8	8 / 8	3 / 8
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.	1 / 3	3 / 3	1 / 3
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.	7 / 25	24 / 25	5 / 25
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.	9 / 25	24 / 25	6 / 25
Part 3 (Dose Extension): Modakafusp Alfa 120 mg Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.	28 / 71	70 / 71	19 / 71
Part 3 (Dose Extension): Modakafusp Alfa 240 mg Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.	33 / 75	74 / 75	20 / 75
Japan Lead-in: Modakafusp Alfa 60 mg Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.	0 / 3	3 / 3	0 / 3
Japan Lead-in: Modakafusp Alfa 120 mg Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.	0 / 2	2 / 2	0 / 2

Group identifiers: EG000: Part 1 (Dose Escalation) Schedule A · EG001: Part 1 (Dose Escalation) Schedule B · EG002: Part 1 (Dose Escalation) Schedule C · EG003: Part 1 (Dose Escalation) Schedule D · EG004: Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa · EG005: Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone · EG006: Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa · EG007: Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone · EG008: Part 3 (Dose Extension): Modakafusp Alfa 120 mg · EG009: Part 3 (Dose Extension): Modakafusp Alfa 240 mg · EG010: Japan Lead-in: Modakafusp Alfa 60 mg · EG011: Japan Lead-in: Modakafusp Alfa 120 mg

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
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Accidental overdose
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
4
num At Risk
71
group Id
EG009
num Affected
2
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
1
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
1
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
71
group Id
EG009
num Affected
2
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Anal incontinence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
2
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
71
group Id
EG009
num Affected
1
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Bacterial 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
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
21
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
2
num At Risk
25
group Id
EG008
num Affected
2
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
71
group Id
EG009
num Affected
1
num At Risk
75
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Acute hepatic failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
2
num At Risk
71
group Id
EG009
num Affected
2
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
1
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
5
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
7
group Id
EG003
num Affected
3
num At Risk
21
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
3
num At Risk
25
group Id
EG007
num Affected
2
num At Risk
25
group Id
EG008
num Affected
6
num At Risk
71
group Id
EG009
num Affected
11
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
4
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
5
num At Risk
20
group Id
EG001
num Affected
5
num At Risk
8
group Id
EG002
num Affected
3
num At Risk
7
group Id
EG003
num Affected
15
num At Risk
21
group Id
EG004
num Affected
3
num At Risk
8
group Id
EG005
num Affected
3
num At Risk
3
group Id
EG006
num Affected
14
num At Risk
25
group Id
EG007
num Affected
11
num At Risk
25
group Id
EG008
num Affected
31
num At Risk
71
group Id
EG009
num Affected
32
num At Risk
75
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
1
num At Risk
25
group Id
EG008
num Affected
2
num At Risk
71
group Id
EG009
num Affected
1
num At Risk
75
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
3
num At Risk
20
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
4
num At Risk
21
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
5
num At Risk
25
group Id
EG007
num Affected
3
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
71
group Id
EG009
num Affected
5
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
5
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
6
num At Risk
21
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
4
num At Risk
25
group Id
EG007
num Affected
4
num At Risk
25
group Id
EG008
num Affected
7
num At Risk
71
group Id
EG009
num Affected
11
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Aspartate aminotransferase increased

Complete source fields

description

The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. As pre-planned Adverse Events data was collected and reported "Per Schedule".

event Groups

deaths Num Affected
15
deaths Num At Risk
20
description
Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
id
EG000
other Num Affected
20
other Num At Risk
20
serious Num Affected
8
serious Num At Risk
20
title
Part 1 (Dose Escalation) Schedule A
deaths Num Affected
6
deaths Num At Risk
8
description
Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
id
EG001
other Num Affected
8
other Num At Risk
8
serious Num Affected
6
serious Num At Risk
8
title
Part 1 (Dose Escalation) Schedule B
deaths Num Affected
6
deaths Num At Risk
7
description
Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
id
EG002
other Num Affected
7
other Num At Risk
7
serious Num Affected
2
serious Num At Risk
7
title
Part 1 (Dose Escalation) Schedule C
deaths Num Affected
8
deaths Num At Risk
21
description
Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
id
EG003
other Num Affected
21
other Num At Risk
21
serious Num Affected
13
serious Num At Risk
21
title
Part 1 (Dose Escalation) Schedule D
deaths Num Affected
3
deaths Num At Risk
8
description
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
id
EG004
other Num Affected
8
other Num At Risk
8
serious Num Affected
1
serious Num At Risk
8
title
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
deaths Num Affected
1
deaths Num At Risk
3
description
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
id
EG005
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
deaths Num Affected
5
deaths Num At Risk
25
description
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
id
EG006
other Num Affected
24
other Num At Risk
25
serious Num Affected
7
serious Num At Risk
25
title
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
deaths Num Affected
6
deaths Num At Risk
25
description
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
id
EG007
other Num Affected
24
other Num At Risk
25
serious Num Affected
9
serious Num At Risk
25
title
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
deaths Num Affected
19
deaths Num At Risk
71
description
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
id
EG008
other Num Affected
70
other Num At Risk
71
serious Num Affected
28
serious Num At Risk
71
title
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
deaths Num Affected
20
deaths Num At Risk
75
description
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
id
EG009
other Num Affected
74
other Num At Risk
75
serious Num Affected
33
serious Num At Risk
75
title
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
deaths Num Affected
0
deaths Num At Risk
3
description
Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
id
EG010
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Japan Lead-in: Modakafusp Alfa 60 mg
deaths Num Affected
0
deaths Num At Risk
2
description
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
id
EG011
other Num Affected
2
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Japan Lead-in: Modakafusp Alfa 120 mg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
21
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
2
num At Risk
25
group Id
EG008
num Affected
2
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
71
group Id
EG009
num Affected
1
num At Risk
75
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Acute hepatic failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
2
num At Risk
71
group Id
EG009
num Affected
2
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
1
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
5
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
7
group Id
EG003
num Affected
3
num At Risk
21
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
3
num At Risk
25
group Id
EG007
num Affected
2
num At Risk
25
group Id
EG008
num Affected
6
num At Risk
71
group Id
EG009
num Affected
11
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
4
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
5
num At Risk
20
group Id
EG001
num Affected
5
num At Risk
8
group Id
EG002
num Affected
3
num At Risk
7
group Id
EG003
num Affected
15
num At Risk
21
group Id
EG004
num Affected
3
num At Risk
8
group Id
EG005
num Affected
3
num At Risk
3
group Id
EG006
num Affected
14
num At Risk
25
group Id
EG007
num Affected
11
num At Risk
25
group Id
EG008
num Affected
31
num At Risk
71
group Id
EG009
num Affected
32
num At Risk
75
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
1
num At Risk
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
2
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
1
num At Risk
25
group Id
EG008
num Affected
2
num At Risk
71
group Id
EG009
num Affected
1
num At Risk
75
group Id
EG010
num Affected
1
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
3
num At Risk
20
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
4
num At Risk
21
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
5
num At Risk
25
group Id
EG007
num Affected
3
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
71
group Id
EG009
num Affected
5
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
5
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
7
group Id
EG003
num Affected
6
num At Risk
21
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
4
num At Risk
25
group Id
EG007
num Affected
4
num At Risk
25
group Id
EG008
num Affected
7
num At Risk
71
group Id
EG009
num Affected
11
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Aspartate aminotransferase increased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Accidental overdose
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
4
num At Risk
71
group Id
EG009
num Affected
2
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
1
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
1
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
71
group Id
EG009
num Affected
2
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Anal incontinence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
2
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
20
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
71
group Id
EG009
num Affected
1
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
20
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
7
group Id
EG003
num Affected
1
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
0
num At Risk
25
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
71
group Id
EG009
num Affected
0
num At Risk
75
group Id
EG010
num Affected
0
num At Risk
3
group Id
EG011
num Affected
0
num At Risk
2
term
Bacterial infection

time Frame

Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3 and Up to 12.1 months in Japan Lead-in

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

Preserved source evidence · Not medical advice