NCT03974022 · ADVERSE EVENTS

Adverse events

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) · 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: Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
Other-event reporting threshold: 5%

No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.	0 / 3	3 / 3	0 / 3
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.	1 / 6	6 / 6	1 / 6
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.	1 / 3	3 / 3	0 / 3
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.	4 / 7	7 / 7	2 / 7
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.	2 / 6	6 / 6	0 / 6
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.	4 / 10	10 / 10	1 / 10
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.	5 / 14	14 / 14	0 / 14
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.	9 / 14	14 / 14	2 / 14
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.	2 / 7	7 / 7	1 / 7
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.	14 / 31	31 / 31	4 / 31
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment. No patient was enrolled into this cohort.	0 / 0	0 / 0	0 / 0
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.	0 / 5	5 / 5	0 / 5
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.	1 / 7	7 / 7	0 / 7
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 200 mg once daily continuously.	37 / 91	91 / 91	33 / 91
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized to receive sunvozertinib 300 mg once daily continuously.	41 / 111	111 / 111	40 / 111

Group identifiers: EG000: Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg · EG001: Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg · EG002: Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg · EG003: Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg · EG004: Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg · EG005: Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State · EG006: Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State · EG007: Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal · EG008: Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal · EG009: Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal · EG010: Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg · EG011: Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted · EG012: Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal · EG013: Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg · EG014: Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 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
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
2
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Aortic valve stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
1
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Stress cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
1
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Anisocoria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
14
group Id
EG007
num Affected
1
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
1
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Colitis

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
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
2
num At Risk
10
group Id
EG006
num Affected
5
num At Risk
14
group Id
EG007
num Affected
3
num At Risk
14
group Id
EG008
num Affected
3
num At Risk
7
group Id
EG009
num Affected
7
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
2
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
2
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Normocytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
1
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Cardiac tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Sinus bradycardia

Complete source fields

description

No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
deaths Num Affected
1
deaths Num At Risk
6
description
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
1
serious Num At Risk
6
title
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
deaths Num Affected
0
deaths Num At Risk
3
description
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
deaths Num Affected
2
deaths Num At Risk
7
description
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
id
EG003
other Num Affected
7
other Num At Risk
7
serious Num Affected
4
serious Num At Risk
7
title
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
deaths Num Affected
0
deaths Num At Risk
6
description
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
id
EG004
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
deaths Num Affected
1
deaths Num At Risk
10
description
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
id
EG005
other Num Affected
10
other Num At Risk
10
serious Num Affected
4
serious Num At Risk
10
title
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
deaths Num Affected
0
deaths Num At Risk
14
description
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
id
EG006
other Num Affected
14
other Num At Risk
14
serious Num Affected
5
serious Num At Risk
14
title
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
deaths Num Affected
2
deaths Num At Risk
14
description
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
id
EG007
other Num Affected
14
other Num At Risk
14
serious Num Affected
9
serious Num At Risk
14
title
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
deaths Num Affected
1
deaths Num At Risk
7
description
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
id
EG008
other Num Affected
7
other Num At Risk
7
serious Num Affected
2
serious Num At Risk
7
title
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
deaths Num Affected
4
deaths Num At Risk
31
description
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
id
EG009
other Num Affected
31
other Num At Risk
31
serious Num Affected
14
serious Num At Risk
31
title
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
deaths Num Affected
0
deaths Num At Risk
0
description
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment. No patient was enrolled into this cohort.
id
EG010
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
deaths Num Affected
0
deaths Num At Risk
5
description
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
id
EG011
other Num Affected
5
other Num At Risk
5
serious Num Affected
0
serious Num At Risk
5
title
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
2
num At Risk
10
group Id
EG006
num Affected
5
num At Risk
14
group Id
EG007
num Affected
3
num At Risk
14
group Id
EG008
num Affected
3
num At Risk
7
group Id
EG009
num Affected
7
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
2
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
2
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Normocytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
1
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Cardiac tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Sinus bradycardia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
2
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Aortic valve stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
1
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Stress cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
1
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Anisocoria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
1
num At Risk
14
group Id
EG007
num Affected
1
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
0
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
10
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
14
group Id
EG008
num Affected
0
num At Risk
7
group Id
EG009
num Affected
1
num At Risk
31
group Id
EG010
num Affected
0
num At Risk
0
group Id
EG011
num Affected
0
num At Risk
5
term
Colitis

time Frame

Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.

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Preserved source evidence · Not medical advice