NCT04844073 · ADVERSE EVENTS

Adverse events

A Study of TAK-186 (Also Known as MVC-101) in Adults With Advanced or Metastatic Cancer · Source last updated 2026-09-24

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: From start of study drug up to 90 days after last dose of the study drug (up to 22 months)
Other-event reporting threshold: 5%

Safety population included all participants who received at least 1 dose of TAK-186.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone Participants received TAK-186, Dose A as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose A is the lowest dose.	0 / 1	1 / 1	1 / 1
Dose Escalation Phase: TAK-186 - Dose B + Dexamethasone Participants received TAK-186, Dose B as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose B is higher than Dose A.	0 / 1	1 / 1	1 / 1
Dose Escalation Phase: TAK-186 - Dose B → Dose C + Dexamethasone Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose C is higher than Dose B.	4 / 5	5 / 5	4 / 5
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone Participants received TAK-186, Dose B on Day 1 followed by Dose D on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B.	7 / 10	10 / 10	6 / 10
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone Participants received of TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose E is higher than Dose C and B.	16 / 17	16 / 17	10 / 17
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.	10 / 13	13 / 13	5 / 13
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose F on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose F is highest dose and is higher than Dose B and C.	4 / 5	5 / 5	2 / 5
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B and C.	4 / 4	4 / 4	3 / 4
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.	6 / 8	8 / 8	5 / 8
Cohort Expansion Phase: NSCLC Participants with NSCLC received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.	24 / 31	31 / 31	12 / 31

Group identifiers: EG000: Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone · EG001: Dose Escalation Phase: TAK-186 - Dose B + Dexamethasone · EG002: Dose Escalation Phase: TAK-186 - Dose B → Dose C + Dexamethasone · EG003: Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone · EG004: Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone · EG005: Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone · EG006: Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone · EG007: Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone · EG008: Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone · EG009: Cohort Expansion Phase: NSCLC

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
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
1
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
3
num At Risk
13
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
1
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
2
num At Risk
31
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
1
num At Risk
31
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
1
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
2
num At Risk
13
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
2
num At Risk
31
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
1
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
1
num At Risk
31
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
1
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Blood creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
1
num At Risk
31
term
Cancer pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
1
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Cerebrovascular accident

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
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
1
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Abdominal abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
1
num At Risk
31
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
2
num At Risk
5
group Id
EG003
num Affected
2
num At Risk
10
group Id
EG004
num Affected
5
num At Risk
17
group Id
EG005
num Affected
1
num At Risk
13
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
2
num At Risk
4
group Id
EG008
num Affected
1
num At Risk
8
group Id
EG009
num Affected
2
num At Risk
31
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
17
group Id
EG005
num Affected
1
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
1
num At Risk
8
group Id
EG009
num Affected
2
num At Risk
31
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
1
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
1
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
4
num At Risk
10
group Id
EG004
num Affected
11
num At Risk
17
group Id
EG005
num Affected
7
num At Risk
13
group Id
EG006
num Affected
4
num At Risk
5
group Id
EG007
num Affected
2
num At Risk
4
group Id
EG008
num Affected
3
num At Risk
8
group Id
EG009
num Affected
12
num At Risk
31
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Alveolar osteitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
2
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
1
num At Risk
31
term
Amylase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
5
num At Risk
17
group Id
EG005
num Affected
5
num At Risk
13
group Id
EG006
num Affected
3
num At Risk
5
group Id
EG007
num Affected
1
num At Risk
4
group Id
EG008
num Affected
3
num At Risk
8
group Id
EG009
num Affected
3
num At Risk
31
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Anal fissure

Complete source fields

description

Safety population included all participants who received at least 1 dose of TAK-186.

event Groups

deaths Num Affected
1
deaths Num At Risk
1
description
Participants received TAK-186, Dose A as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose A is the lowest dose.
id
EG000
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone
deaths Num Affected
1
deaths Num At Risk
1
description
Participants received TAK-186, Dose B as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose B is higher than Dose A.
id
EG001
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Dose Escalation Phase: TAK-186 - Dose B + Dexamethasone
deaths Num Affected
4
deaths Num At Risk
5
description
Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose C is higher than Dose B.
id
EG002
other Num Affected
5
other Num At Risk
5
serious Num Affected
4
serious Num At Risk
5
title
Dose Escalation Phase: TAK-186 - Dose B → Dose C + Dexamethasone
deaths Num Affected
6
deaths Num At Risk
10
description
Participants received TAK-186, Dose B on Day 1 followed by Dose D on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B.
id
EG003
other Num Affected
10
other Num At Risk
10
serious Num Affected
7
serious Num At Risk
10
title
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone
deaths Num Affected
10
deaths Num At Risk
17
description
Participants received of TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose E is higher than Dose C and B.
id
EG004
other Num Affected
16
other Num At Risk
17
serious Num Affected
16
serious Num At Risk
17
title
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone
deaths Num Affected
5
deaths Num At Risk
13
description
Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.
id
EG005
other Num Affected
13
other Num At Risk
13
serious Num Affected
10
serious Num At Risk
13
title
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose E + Double Dexamethasone
deaths Num Affected
2
deaths Num At Risk
5
description
Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose F on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose F is highest dose and is higher than Dose B and C.
id
EG006
other Num Affected
5
other Num At Risk
5
serious Num Affected
4
serious Num At Risk
5
title
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose F + Dexamethasone
deaths Num Affected
3
deaths Num At Risk
4
description
Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B and C.
id
EG007
other Num Affected
4
other Num At Risk
4
serious Num Affected
4
serious Num At Risk
4
title
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone
deaths Num Affected
5
deaths Num At Risk
8
description
Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.
id
EG008
other Num Affected
8
other Num At Risk
8
serious Num Affected
6
serious Num At Risk
8
title
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Double Dexamethasone
deaths Num Affected
12
deaths Num At Risk
31
description
Participants with NSCLC received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.
id
EG009
other Num Affected
31
other Num At Risk
31
serious Num Affected
24
serious Num At Risk
31
title
Cohort Expansion Phase: NSCLC

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
1
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Abdominal abscess
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
1
num At Risk
31
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
2
num At Risk
5
group Id
EG003
num Affected
2
num At Risk
10
group Id
EG004
num Affected
5
num At Risk
17
group Id
EG005
num Affected
1
num At Risk
13
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
2
num At Risk
4
group Id
EG008
num Affected
1
num At Risk
8
group Id
EG009
num Affected
2
num At Risk
31
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
3
num At Risk
17
group Id
EG005
num Affected
1
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
1
num At Risk
8
group Id
EG009
num Affected
2
num At Risk
31
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
1
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
1
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
4
num At Risk
10
group Id
EG004
num Affected
11
num At Risk
17
group Id
EG005
num Affected
7
num At Risk
13
group Id
EG006
num Affected
4
num At Risk
5
group Id
EG007
num Affected
2
num At Risk
4
group Id
EG008
num Affected
3
num At Risk
8
group Id
EG009
num Affected
12
num At Risk
31
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Alveolar osteitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
2
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
1
num At Risk
31
term
Amylase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
1
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
5
num At Risk
17
group Id
EG005
num Affected
5
num At Risk
13
group Id
EG006
num Affected
3
num At Risk
5
group Id
EG007
num Affected
1
num At Risk
4
group Id
EG008
num Affected
3
num At Risk
8
group Id
EG009
num Affected
3
num At Risk
31
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Anal fissure

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
1
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
3
num At Risk
13
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
1
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
2
num At Risk
31
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
1
num At Risk
31
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
1
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
2
num At Risk
13
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
2
num At Risk
31
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
1
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
1
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
1
num At Risk
31
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
1
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Blood creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
1
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
0
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
1
num At Risk
31
term
Cancer pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
1
group Id
EG001
num Affected
0
num At Risk
1
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
10
group Id
EG004
num Affected
0
num At Risk
17
group Id
EG005
num Affected
0
num At Risk
13
group Id
EG006
num Affected
0
num At Risk
5
group Id
EG007
num Affected
1
num At Risk
4
group Id
EG008
num Affected
0
num At Risk
8
group Id
EG009
num Affected
0
num At Risk
31
term
Cerebrovascular accident

time Frame

From start of study drug up to 90 days after last dose of the study drug (up to 22 months)

Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0

Preserved source evidence · Not medical advice