NCT04579380 · ADVERSE EVENTS

Adverse events

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations · Source last updated 2026-08-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)
Other-event reporting threshold: 5%

Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Tucatinib+Trastuzumab (Cohort 1) Participants with cervical cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.	5 / 11	10 / 11	9 / 11
Tucatinib+Trastuzumab (Cohort 2) Participants with uterine cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.	11 / 31	30 / 31	22 / 31
Tucatinib+Trastuzumab (Cohort 3) Participants with biliary tract cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure	13 / 30	29 / 30	22 / 30
Tucatinib+Trastuzumab (Cohort 4) Participants with urothelial cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.	9 / 25	23 / 25	17 / 25
Tucatinib+Trastuzumab (Cohort 5) Participants with NSCLC with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.	2 / 12	12 / 12	6 / 12
Tucatinib+Trastuzumab (Cohort 6) Participants with solid tumor types (except breast, gastric or GEC, and CRC) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.	9 / 31	29 / 31	21 / 31
Tucatinib+Trastuzumab (Cohort 7) Participants with non-squamous NSCLC with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.	7 / 13	13 / 13	10 / 13
Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8) Participants with breast cancer with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants with hormone-receptor positive breast cancer also received fulvestrant 500 mg IM once every 4 weeks starting from Day 1 of Cycle 1, and on Day 15 of Cycle 1. Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.	8 / 31	31 / 31	11 / 31
Tucatinib+Trastuzumab (Cohort 9) Participants with all solid tumor cancers (except breast and non-squamous NSCLC) with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.	14 / 33	30 / 33	25 / 33

Group identifiers: EG000: Tucatinib+Trastuzumab (Cohort 1) · EG001: Tucatinib+Trastuzumab (Cohort 2) · EG002: Tucatinib+Trastuzumab (Cohort 3) · EG003: Tucatinib+Trastuzumab (Cohort 4) · EG004: Tucatinib+Trastuzumab (Cohort 5) · EG005: Tucatinib+Trastuzumab (Cohort 6) · EG006: Tucatinib+Trastuzumab (Cohort 7) · EG007: Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8) · EG008: Tucatinib+Trastuzumab (Cohort 9)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
31
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
1
num At Risk
33
num Events
1
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
31
num Events
1
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Optic neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
1
num At Risk
25
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Retinal detachment
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
31
num Events
1
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
2
num At Risk
33
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
1
num At Risk
30
num Events
1
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
1
num At Risk
31
num Events
1
group Id
EG008
num Affected
1
num At Risk
33
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
1
num At Risk
33
num Events
1
term
Duodenal perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Dysphagia

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 v26.0
stats
group Id
EG000
num Affected
3
num At Risk
11
num Events
3
group Id
EG001
num Affected
6
num At Risk
31
num Events
8
group Id
EG002
num Affected
4
num At Risk
30
num Events
4
group Id
EG003
num Affected
7
num At Risk
25
num Events
13
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
5
num At Risk
31
num Events
5
group Id
EG006
num Affected
2
num At Risk
13
num Events
2
group Id
EG007
num Affected
3
num At Risk
31
num Events
3
group Id
EG008
num Affected
5
num At Risk
33
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
3
group Id
EG001
num Affected
1
num At Risk
31
num Events
2
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
31
num Events
1
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
2
num At Risk
31
num Events
4
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
1
num At Risk
33
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
1
num At Risk
25
num Events
1
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
31
num Events
1
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
2
num At Risk
31
num Events
2
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Eye irritation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Eyelid ptosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
2
num At Risk
31
num Events
2
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
1
num At Risk
25
num Events
2
group Id
EG004
num Affected
2
num At Risk
12
num Events
2
group Id
EG005
num Affected
3
num At Risk
31
num Events
3
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Abdominal distension

Complete source fields

description

event Groups

deaths Num Affected
9
deaths Num At Risk
11
description
Participants with cervical cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
id
EG000
other Num Affected
10
other Num At Risk
11
serious Num Affected
5
serious Num At Risk
11
title
Tucatinib+Trastuzumab (Cohort 1)
deaths Num Affected
22
deaths Num At Risk
31
description
Participants with uterine cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
id
EG001
other Num Affected
30
other Num At Risk
31
serious Num Affected
11
serious Num At Risk
31
title
Tucatinib+Trastuzumab (Cohort 2)
deaths Num Affected
22
deaths Num At Risk
30
description
Participants with biliary tract cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure
id
EG002
other Num Affected
29
other Num At Risk
30
serious Num Affected
13
serious Num At Risk
30
title
Tucatinib+Trastuzumab (Cohort 3)
deaths Num Affected
17
deaths Num At Risk
25
description
Participants with urothelial cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
id
EG003
other Num Affected
23
other Num At Risk
25
serious Num Affected
9
serious Num At Risk
25
title
Tucatinib+Trastuzumab (Cohort 4)
deaths Num Affected
6
deaths Num At Risk
12
description
Participants with NSCLC with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
id
EG004
other Num Affected
12
other Num At Risk
12
serious Num Affected
2
serious Num At Risk
12
title
Tucatinib+Trastuzumab (Cohort 5)
deaths Num Affected
21
deaths Num At Risk
31
description
Participants with solid tumor types (except breast, gastric or GEC, and CRC) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
id
EG005
other Num Affected
29
other Num At Risk
31
serious Num Affected
9
serious Num At Risk
31
title
Tucatinib+Trastuzumab (Cohort 6)
deaths Num Affected
10
deaths Num At Risk
13
description
Participants with non-squamous NSCLC with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
id
EG006
other Num Affected
13
other Num At Risk
13
serious Num Affected
7
serious Num At Risk
13
title
Tucatinib+Trastuzumab (Cohort 7)
deaths Num Affected
11
deaths Num At Risk
31
description
Participants with breast cancer with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants with hormone-receptor positive breast cancer also received fulvestrant 500 mg IM once every 4 weeks starting from Day 1 of Cycle 1, and on Day 15 of Cycle 1. Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
id
EG007
other Num Affected
31
other Num At Risk
31
serious Num Affected
8
serious Num At Risk
31
title
Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)
deaths Num Affected
25
deaths Num At Risk
33
description
Participants with all solid tumor cancers (except breast and non-squamous NSCLC) with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
id
EG008
other Num Affected
30
other Num At Risk
33
serious Num Affected
14
serious Num At Risk
33
title
Tucatinib+Trastuzumab (Cohort 9)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
3
num At Risk
11
num Events
3
group Id
EG001
num Affected
6
num At Risk
31
num Events
8
group Id
EG002
num Affected
4
num At Risk
30
num Events
4
group Id
EG003
num Affected
7
num At Risk
25
num Events
13
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
5
num At Risk
31
num Events
5
group Id
EG006
num Affected
2
num At Risk
13
num Events
2
group Id
EG007
num Affected
3
num At Risk
31
num Events
3
group Id
EG008
num Affected
5
num At Risk
33
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
3
group Id
EG001
num Affected
1
num At Risk
31
num Events
2
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
31
num Events
1
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
2
num At Risk
31
num Events
4
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
1
num At Risk
33
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
1
num At Risk
25
num Events
1
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
31
num Events
1
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
2
num At Risk
31
num Events
2
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Eye irritation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Eyelid ptosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
2
num At Risk
31
num Events
2
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
1
num At Risk
25
num Events
2
group Id
EG004
num Affected
2
num At Risk
12
num Events
2
group Id
EG005
num Affected
3
num At Risk
31
num Events
3
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Abdominal distension

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
31
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
1
num At Risk
33
num Events
1
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
1
num At Risk
12
num Events
1
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
31
num Events
1
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
31
num Events
1
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Optic neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
1
num At Risk
25
num Events
1
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Retinal detachment
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
1
num At Risk
31
num Events
1
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
2
num At Risk
33
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
1
num At Risk
30
num Events
1
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
1
num At Risk
31
num Events
1
group Id
EG008
num Affected
1
num At Risk
33
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
1
num At Risk
33
num Events
1
term
Duodenal perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
31
num Events
0
group Id
EG002
num Affected
0
num At Risk
30
num Events
0
group Id
EG003
num Affected
0
num At Risk
25
num Events
0
group Id
EG004
num Affected
0
num At Risk
12
num Events
0
group Id
EG005
num Affected
0
num At Risk
31
num Events
0
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
0
num At Risk
31
num Events
0
group Id
EG008
num Affected
0
num At Risk
33
num Events
0
term
Dysphagia

time Frame

From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice