Trial Outcomes & Findings for Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors (NCT NCT02564900)
NCT ID: NCT02564900
Last Updated: 2024-01-22
Results Overview
Objective response rate (ORR) by independent central review was defined as the proportion of participants who achieve either complete response \[CR\] or partial response \[PR\] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
292 participants
Primary outcome timeframe
From 6 months postdose of last participant up to 3 years 5 months
Results posted on
2024-01-22
Participant Flow
A total of 292 participants who met all inclusion and no exclusion criteria were enrolled at 8 centers in the US and 6 centers in Japan. A total of 27 participants started the Dose Escalation phase and a total of 265 participants in the Dose Expansion phase.
The Dose Escalation was intended to identify the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of DS-8201a with at least 3 participants evaluable for assessment of dose-limiting toxicity per dose level. Since the MTD was not reached, doses of 5.4 mg/kg and 6.4 mg/kg were chosen for evaluation in the Dose Expansion phase.
Participant milestones
| Measure |
Dose Escalation: Cohort 1, 0.8 mg/kg
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 2, 1.6 mg/kg
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 3, 3.2 mg/kg
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 4, 5.4 mg/kg
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 5, 6.4 mg/kg
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 6, 8.0 mg/kg
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing NSCLC Tumors
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation
STARTED
|
3
|
3
|
3
|
6
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
NOT COMPLETED
|
3
|
3
|
3
|
6
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
49
|
62
|
20
|
33
|
17
|
24
|
18
|
20
|
22
|
|
Dose Expansion
Enrolled, But Not Dosed
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Dose Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
49
|
62
|
20
|
33
|
17
|
24
|
18
|
20
|
22
|
Reasons for withdrawal
| Measure |
Dose Escalation: Cohort 1, 0.8 mg/kg
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 2, 1.6 mg/kg
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 3, 3.2 mg/kg
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 4, 5.4 mg/kg
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 5, 6.4 mg/kg
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 6, 8.0 mg/kg
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing NSCLC Tumors
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation
Progressive disease per RECIST
|
2
|
3
|
3
|
3
|
3
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
Ongoing
|
1
|
0
|
0
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
Adverse Event
|
0
|
0
|
0
|
1
|
1
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion
Progressive disease per RECIST
|
0
|
0
|
0
|
0
|
0
|
0
|
19
|
17
|
8
|
16
|
13
|
19
|
10
|
13
|
11
|
|
Dose Expansion
Clinical progression
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
12
|
0
|
3
|
2
|
0
|
1
|
3
|
1
|
|
Dose Expansion
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
22
|
0
|
11
|
0
|
5
|
2
|
2
|
1
|
|
Dose Expansion
Ongoing
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
10
|
11
|
3
|
0
|
0
|
4
|
0
|
6
|
|
Dose Expansion
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
|
Dose Expansion
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
|
Dose Expansion
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Dose Expansion
Did not receive treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
Baseline characteristics by cohort
| Measure |
Dose Escalation: Cohort 1, 0.8 mg/kg
n=3 Participants
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 2, 1.6 mg/kg
n=3 Participants
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 3, 3.2 mg/kg
n=3 Participants
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 4, 5.4 mg/kg
n=6 Participants
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 5, 6.4 mg/kg
n=6 Participants
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 6, 8.0 mg/kg
n=6 Participants
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
n=49 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
n=62 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
n=20 Participants
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
n=33 Participants
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
n=17 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
n=24 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing NSCLC Tumors
n=18 Participants
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Colorectal Tumors
n=20 Participants
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Other Solid Tumors
n=22 Participants
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Total
n=292 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
33 Participants
n=115 Participants
|
48 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
16 Participants
n=36 Participants
|
16 Participants
n=24 Participants
|
191 Participants
n=135 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
14 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
101 Participants
n=135 Participants
|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 7.09 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 4.73 • n=7 Participants
|
48.3 years
STANDARD_DEVIATION 14.57 • n=5 Participants
|
66.8 years
STANDARD_DEVIATION 14.82 • n=4 Participants
|
58.2 years
STANDARD_DEVIATION 10.40 • n=21 Participants
|
66.2 years
STANDARD_DEVIATION 10.67 • n=10 Participants
|
56.2 years
STANDARD_DEVIATION 12.11 • n=115 Participants
|
54.9 years
STANDARD_DEVIATION 10.28 • n=24 Participants
|
57.8 years
STANDARD_DEVIATION 9.68 • n=42 Participants
|
56.3 years
STANDARD_DEVIATION 10.97 • n=42 Participants
|
64.2 years
STANDARD_DEVIATION 11.00 • n=42 Participants
|
66.2 years
STANDARD_DEVIATION 8.55 • n=42 Participants
|
57.4 years
STANDARD_DEVIATION 15.29 • n=36 Participants
|
59.5 years
STANDARD_DEVIATION 9.90 • n=36 Participants
|
58.5 years
STANDARD_DEVIATION 10.16 • n=24 Participants
|
58.1 years
STANDARD_DEVIATION 11.39 • n=135 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
48 Participants
n=115 Participants
|
62 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
33 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
13 Participants
n=36 Participants
|
9 Participants
n=36 Participants
|
9 Participants
n=24 Participants
|
229 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
11 Participants
n=36 Participants
|
13 Participants
n=24 Participants
|
63 Participants
n=135 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
40 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
17 Participants
n=36 Participants
|
14 Participants
n=24 Participants
|
193 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
8 Participants
n=135 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
19 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
7 Participants
n=24 Participants
|
83 Participants
n=135 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=135 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=10 Participants
|
30 participants
n=115 Participants
|
25 participants
n=24 Participants
|
16 participants
n=42 Participants
|
11 participants
n=42 Participants
|
5 participants
n=42 Participants
|
0 participants
n=42 Participants
|
10 participants
n=36 Participants
|
3 participants
n=36 Participants
|
9 participants
n=24 Participants
|
112 participants
n=135 Participants
|
|
Region of Enrollment
Japan
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
3 participants
n=10 Participants
|
19 participants
n=115 Participants
|
37 participants
n=24 Participants
|
4 participants
n=42 Participants
|
22 participants
n=42 Participants
|
12 participants
n=42 Participants
|
24 participants
n=42 Participants
|
8 participants
n=36 Participants
|
17 participants
n=36 Participants
|
13 participants
n=24 Participants
|
180 participants
n=135 Participants
|
PRIMARY outcome
Timeframe: From 6 months postdose of last participant up to 3 years 5 monthsPopulation: ORR was assessed among participants in the Intent-to-Treat Analysis Set.
Objective response rate (ORR) by independent central review was defined as the proportion of participants who achieve either complete response \[CR\] or partial response \[PR\] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
Outcome measures
| Measure |
Dose Escalation: Cohort 1, 0.8 mg/kg
n=3 Participants
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 2, 1.6 mg/kg
n=3 Participants
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 3, 3.2 mg/kg
n=3 Participants
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 4, 5.4 mg/kg
n=6 Participants
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 5, 6.4 mg/kg
n=6 Participants
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 6, 8.0 mg/kg
n=6 Participants
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
n=51 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
n=67 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
n=21 Participants
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
n=33 Participants
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
n=19 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
n=25 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing NSCLC Tumors
n=18 Participants
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Colorectal Tumors
n=20 Participants
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Other Solid Tumors
n=23 Participants
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
|
0 percentage of participants
Interval 0.0 to 70.8
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
0 percentage of participants
Interval 0.0 to 70.8
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
51.0 percentage of participants
Interval 36.6 to 65.2
|
53.7 percentage of participants
Interval 41.1 to 66.0
|
33.3 percentage of participants
Interval 14.6 to 57.0
|
39.4 percentage of participants
Interval 22.9 to 57.9
|
26.3 percentage of participants
Interval 9.1 to 51.2
|
32.0 percentage of participants
Interval 14.9 to 53.5
|
55.6 percentage of participants
Interval 30.8 to 78.5
|
5.0 percentage of participants
Interval 0.1 to 24.9
|
30.4 percentage of participants
Interval 13.2 to 52.9
|
SECONDARY outcome
Timeframe: From 6 months postdose of last participant up to 3 years 5 monthsPopulation: DCR was assessed in the Intent-to-Treat Analysis Set.
Disease control rate (DCR) by independent central review was calculated as the proportion of participants demonstrating complete response (CR), partial response (PR), or stable disease (SD) for a minimum of 6 weeks (±1week) from the first dosing date. CR was defined as a disappearance of all target lesions, PR as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included 8 participants with salivary/submandibular/parotid gland, 2 breast with HER2-mutation, 2 endometrial, 2 esophageal, 2 Paget's disease, 1 cholangiocarcinoma, 1 extraskeletal myxoide chondrosarcoma, 1 gallbladder, 1 pancreatic, 1 small intestine, 1 uterine cervix, and 1 participant who received 5.4 mg/kg with HER2-low gastric/GEJ cancer.
Outcome measures
| Measure |
Dose Escalation: Cohort 1, 0.8 mg/kg
n=3 Participants
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 2, 1.6 mg/kg
n=3 Participants
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 3, 3.2 mg/kg
n=3 Participants
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 4, 5.4 mg/kg
n=6 Participants
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 5, 6.4 mg/kg
n=6 Participants
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 6, 8.0 mg/kg
n=6 Participants
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
n=51 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
n=67 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
n=21 Participants
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
n=33 Participants
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
n=19 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
n=25 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing NSCLC Tumors
n=18 Participants
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Colorectal Tumors
n=20 Participants
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Other Solid Tumors
n=23 Participants
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
100.0 percentage of participants
Interval 54.1 to 100.0
|
100.0 percentage of participants
Interval 54.1 to 100.0
|
100.0 percentage of participants
Interval 54.1 to 100.0
|
88.2 percentage of participants
Interval 76.1 to 95.6
|
95.5 percentage of participants
Interval 87.5 to 99.1
|
85.7 percentage of participants
Interval 63.7 to 97.0
|
87.9 percentage of participants
Interval 71.8 to 96.6
|
78.9 percentage of participants
Interval 54.4 to 93.9
|
88.0 percentage of participants
Interval 68.8 to 97.5
|
83.3 percentage of participants
Interval 58.6 to 96.4
|
80.0 percentage of participants
Interval 56.3 to 94.3
|
82.6 percentage of participants
Interval 61.2 to 95.0
|
SECONDARY outcome
Timeframe: From 6 months postdose of last participant up to 3 years 5 monthsPopulation: Best overall response was assessed in the Intent-to-Treat Analysis Set.
Best overall response by independent central review was defined as the proportion of participants who achieved either complete response \[CR\], partial response \[PR\], stable disease (SD), progressive disease (PD), or were non-evaluable (NE) as per RECIST v1.1. CR was defined as a disappearance of all target lesions, PR at least a 30% decrease in the sum of diameters of target lesions, and SD as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD defined as at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included 8 participants with salivary/submandibular/parotid gland, 2 breast with HER2-mutation, 2 endometrial, 2 esophageal, 2 Paget's disease, 1 cholangiocarcinoma, 1 extraskeletal myxoide chondrosarcoma, 1 gallbladder, 1 pancreatic, 1 small intestine, 1 uterine cervix, and 1 participant who received 5.4 mg/kg with HER2-low gastric/GEJ cancer.
Outcome measures
| Measure |
Dose Escalation: Cohort 1, 0.8 mg/kg
n=3 Participants
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 2, 1.6 mg/kg
n=3 Participants
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 3, 3.2 mg/kg
n=3 Participants
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 4, 5.4 mg/kg
n=6 Participants
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 5, 6.4 mg/kg
n=6 Participants
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 6, 8.0 mg/kg
n=6 Participants
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
n=51 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
n=67 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
n=21 Participants
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
n=33 Participants
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
n=19 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
n=25 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing NSCLC Tumors
n=18 Participants
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Colorectal Tumors
n=20 Participants
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Other Solid Tumors
n=23 Participants
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Best Overall Response Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Complete response
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Best Overall Response Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Partial response
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
24 Participants
|
28 Participants
|
7 Participants
|
13 Participants
|
5 Participants
|
7 Participants
|
10 Participants
|
1 Participants
|
5 Participants
|
|
Best Overall Response Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Stable disease
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
19 Participants
|
28 Participants
|
11 Participants
|
16 Participants
|
10 Participants
|
14 Participants
|
5 Participants
|
15 Participants
|
12 Participants
|
|
Best Overall Response Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Progressive disease
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Best Overall Response Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Non-evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From 6 months postdose of last participant up to 3 years 5 monthsPopulation: DoR was assessed among participants who achieved a CR or PR in the Intent-to-Treat Analysis Set.
Duration of response (DoR) by independent central review was defined as the time between the date of the first complete response (CR) or partial response (PR) until the date of the first documentation of progressive disease (PD) or death due to any cause. CR was defined as a disappearance of all target lesions, PR as at least a 30% decrease in the sum of diameters of target lesions, and PD as at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
Outcome measures
| Measure |
Dose Escalation: Cohort 1, 0.8 mg/kg
n=51 Participants
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 2, 1.6 mg/kg
n=67 Participants
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 3, 3.2 mg/kg
n=21 Participants
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 4, 5.4 mg/kg
n=33 Participants
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 5, 6.4 mg/kg
n=19 Participants
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 6, 8.0 mg/kg
n=25 Participants
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
n=18 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
n=20 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
n=23 Participants
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing NSCLC Tumors
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
|
12.7 months
Interval 6.7 to
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
|
13.6 months
Interval 7.3 to
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
|
NA months
Lack of a median value is due to less than 50% of the participants experiencing the event. In a Kaplan-Meier analysis, the curve would never fall below the 50% mark, and would continue to the largest observed censored time value.
|
10.4 months
Interval 3.4 to
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
|
5.6 months
Interval 2.9 to
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
|
6.9 months
Interval 3.5 to
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
|
10.7 months
Interval 6.9 to 11.5
|
13.4 months
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
|
NA months
Interval 3.0 to
Median and 95% confidence interval were not calculable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From 6 months postdose of last participant up to 3 years 5 monthsPopulation: Time to response was assessed among participants who achieved CR or PR in the Intent-to-Treat Analysis Set.
Time to response (TTR) by independent central review was defined as the time interval between the date of registration until the date at which the criteria were first met for complete response (CR) or partial response (PR). Only participants who achieved CR or PR were included in the TTR analysis. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
Outcome measures
| Measure |
Dose Escalation: Cohort 1, 0.8 mg/kg
n=51 Participants
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 2, 1.6 mg/kg
n=67 Participants
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 3, 3.2 mg/kg
n=21 Participants
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 4, 5.4 mg/kg
n=33 Participants
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 5, 6.4 mg/kg
n=19 Participants
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 6, 8.0 mg/kg
n=25 Participants
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
n=18 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
n=20 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
n=23 Participants
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing NSCLC Tumors
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Response (TTR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
|
2.7 months
Interval 1.5 to 2.9
|
2.8 months
Interval 1.4 to 2.9
|
2.6 months
Interval 1.2 to 4.2
|
2.7 months
Interval 1.2 to 3.1
|
1.6 months
Interval 1.2 to 3.1
|
2.2 months
Interval 1.4 to 2.9
|
1.4 months
Interval 1.2 to 2.8
|
3.0 months
The 95% confidence interval was not calculable due to insufficient number of participants with events.
|
1.6 months
Interval 1.2 to 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From 6 months postdose of last participant up to 3 years 5 monthsPopulation: PFS was assessed in the Intent-to-Treat Analysis Set.
Progression-free survival (PFS) by independent central review was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
Outcome measures
| Measure |
Dose Escalation: Cohort 1, 0.8 mg/kg
n=51 Participants
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 2, 1.6 mg/kg
n=67 Participants
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 3, 3.2 mg/kg
n=21 Participants
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 4, 5.4 mg/kg
n=33 Participants
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 5, 6.4 mg/kg
n=19 Participants
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 6, 8.0 mg/kg
n=25 Participants
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
n=18 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
n=20 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
n=23 Participants
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing NSCLC Tumors
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
|
13.7 months
Interval 8.5 to 19.6
|
14.1 months
Interval 8.5 to
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
|
NA months
Interval 2.7 to
Median and 95% confidence interval were not calculable due to insufficient number of participants with events.
|
11.1 months
Interval 5.0 to
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
|
4.3 months
Interval 2.6 to 8.6
|
8.2 months
Interval 4.2 to 11.0
|
11.3 months
Interval 7.2 to 14.3
|
4.0 months
Interval 2.7 to 5.6
|
11.0 months
Interval 2.8 to
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From 6 months postdose of last participant up to 3 years 5 monthsPopulation: OS was assessed in the Intent-to-Treat Analysis Set.
Overall survival (OS) by independent central review was defined as the time interval from the date of enrollment to the date of death from any cause. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
Outcome measures
| Measure |
Dose Escalation: Cohort 1, 0.8 mg/kg
n=51 Participants
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 2, 1.6 mg/kg
n=67 Participants
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 3, 3.2 mg/kg
n=21 Participants
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 4, 5.4 mg/kg
n=33 Participants
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 5, 6.4 mg/kg
n=19 Participants
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 6, 8.0 mg/kg
n=25 Participants
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
n=18 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
n=20 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
n=23 Participants
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing NSCLC Tumors
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival Among Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
|
NA months
Lack of median value is due to less than 50% of the participants experiencing the event. In a Kaplan-Meier analysis, the curve would never fall below the 50% mark, and would continue to the largest observed censored time value.
|
NA months
Interval 26.4 to
Median and 95% confidence interval were not calculable due to insufficient number of participants with events.
|
NA months
Lack of median value is due to less than 50% of the participants experiencing the event. In a Kaplan-Meier analysis, the curve would never fall below the 50% mark, and would continue to the largest observed censored time value.
|
19.7 months
Interval 12.5 to 29.4
|
18.9 months
Interval 5.7 to
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
|
26.2 months
Interval 10.0 to
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
|
NA months
Interval 17.3 to
Median and 95% confidence interval were not calculable due to insufficient number of participants with events.
|
15.6 months
Interval 4.8 to
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
|
23.4 months
Interval 9.7 to
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Post first dose up to Day 147Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
The serum PK parameters of DS-8201a and its analytes for area under the concentration-versus-time curve from time 0 to the last quantifiable concentration as calculated by the linear-up log-down trapezoidal method (AUClast) and AUC from time 0 to infinity (AUCinf) elimination rate constant associated with the terminal phase were estimated using standard non-compartmental methods.
Outcome measures
| Measure |
Dose Escalation: Cohort 1, 0.8 mg/kg
n=3 Participants
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 2, 1.6 mg/kg
n=3 Participants
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 3, 3.2 mg/kg
n=3 Participants
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 4, 5.4 mg/kg
n=6 Participants
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 5, 6.4 mg/kg
n=6 Participants
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 6, 8.0 mg/kg
n=5 Participants
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
n=48 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
n=50 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
n=20 Participants
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
n=19 Participants
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
n=17 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
n=23 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing NSCLC Tumors
n=58 Participants
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Colorectal Tumors
n=21 Participants
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Analysis: Area Under the Concentration Versus Time Curve (AUC) of Serum DS-8201a Following First Dose
AUClast
|
51.7 ug*d/mL
Standard Deviation 13.1
|
116 ug*d/mL
Standard Deviation 58.7
|
325 ug*d/mL
Standard Deviation 142
|
544 ug*d/mL
Standard Deviation 165
|
901 ug*d/mL
Standard Deviation 155
|
996 ug*d/mL
Standard Deviation 229
|
559 ug*d/mL
Standard Deviation 178
|
785 ug*d/mL
Standard Deviation 228
|
581 ug*d/mL
Standard Deviation 180
|
693 ug*d/mL
Standard Deviation 178
|
542 ug*d/mL
Standard Deviation 163
|
507 ug*d/mL
Standard Deviation 126
|
631 ug*d/mL
Standard Deviation 184
|
693 ug*d/mL
Standard Deviation 102
|
—
|
|
Pharmacokinetic (PK) Analysis: Area Under the Concentration Versus Time Curve (AUC) of Serum DS-8201a Following First Dose
AUCinfinity
|
55.0 ug*d/mL
Standard Deviation 11.9
|
121 ug*d/mL
Standard Deviation 58.9
|
340 ug*d/mL
Standard Deviation 150
|
590 ug*d/mL
Standard Deviation 186
|
1030 ug*d/mL
Standard Deviation 209
|
1100 ug*d/mL
Standard Deviation 259
|
602 ug*d/mL
Standard Deviation 203
|
848 ug*d/mL
Standard Deviation 243
|
589 ug*d/mL
Standard Deviation 145
|
762 ug*d/mL
Standard Deviation 205
|
596 ug*d/mL
Standard Deviation 183
|
563 ug*d/mL
Standard Deviation 151
|
683 ug*d/mL
Standard Deviation 209
|
753 ug*d/mL
Standard Deviation 118
|
—
|
SECONDARY outcome
Timeframe: Post first dose up to Day 147Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
The serum PK parameters Maximum (peak) Observed serum concentration of DS-8201a and its analytes were estimated using standard non-compartmental method.
Outcome measures
| Measure |
Dose Escalation: Cohort 1, 0.8 mg/kg
n=3 Participants
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 2, 1.6 mg/kg
n=3 Participants
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 3, 3.2 mg/kg
n=3 Participants
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 4, 5.4 mg/kg
n=6 Participants
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 5, 6.4 mg/kg
n=6 Participants
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 6, 8.0 mg/kg
n=5 Participants
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
n=48 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
n=50 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
n=20 Participants
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
n=19 Participants
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
n=17 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
n=23 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing NSCLC Tumors
n=59 Participants
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Colorectal Tumors
n=21 Participants
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Analysis: Maximum (Peak) Observed Serum Concentration (Cmax) of Serum DS-8201a Following First Dose
|
22.9 ug/mL
Standard Deviation 3.76
|
36.2 ug/mL
Standard Deviation 4.98
|
78.2 ug/mL
Standard Deviation 16.1
|
127 ug/mL
Standard Deviation 17.2
|
181 ug/mL
Standard Deviation 33.1
|
221 ug/mL
Standard Deviation 41.0
|
126 ug/mL
Standard Deviation 37.7
|
170 ug/mL
Standard Deviation 53.6
|
133 ug/mL
Standard Deviation 18.3
|
155 ug/mL
Standard Deviation 33.2
|
113 ug/mL
Standard Deviation 30.0
|
116 ug/mL
Standard Deviation 21.1
|
150 ug/mL
Standard Deviation 30.3
|
155 ug/mL
Standard Deviation 21.4
|
—
|
SECONDARY outcome
Timeframe: Post first dose up to Day 147Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
The serum PK parameters of Time of maximum plasma concentration (Tmax) for DS-8201a and its analytes were estimated using standard non-compartmental methods.
Outcome measures
| Measure |
Dose Escalation: Cohort 1, 0.8 mg/kg
n=3 Participants
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 2, 1.6 mg/kg
n=3 Participants
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 3, 3.2 mg/kg
n=3 Participants
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 4, 5.4 mg/kg
n=6 Participants
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 5, 6.4 mg/kg
n=6 Participants
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 6, 8.0 mg/kg
n=5 Participants
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
n=48 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
n=50 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
n=20 Participants
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
n=19 Participants
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
n=17 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
n=23 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing NSCLC Tumors
n=59 Participants
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Colorectal Tumors
n=21 Participants
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Analysis: Time of Maximum Plasma Concentration (Tmax) of Serum DS-8201a Following First Dose
|
1.95 hours
Interval 1.62 to 1.98
|
4.03 hours
Interval 1.87 to 4.08
|
4.12 hours
Interval 1.95 to 6.88
|
2.02 hours
Interval 1.87 to 2.07
|
2.06 hours
Interval 1.5 to 3.97
|
1.97 hours
Interval 1.7 to 6.8
|
2.00 hours
Interval 1.5 to 6.85
|
2.08 hours
Interval 1.53 to 7.05
|
2.16 hours
Interval 1.5 to 7.07
|
2.00 hours
Interval 1.5 to 6.67
|
2.03 hours
Interval 1.58 to 4.08
|
1.95 hours
Interval 1.53 to 7.0
|
2.02 hours
Interval 1.5 to 7.2
|
2.05 hours
Interval 1.62 to 7.23
|
—
|
SECONDARY outcome
Timeframe: Post first dose up to Day 147Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
The serum PK parameters of Terminal elimination half-life for DS-8201a and its analytes was estimated using standard non-compartmental methods.
Outcome measures
| Measure |
Dose Escalation: Cohort 1, 0.8 mg/kg
n=3 Participants
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 2, 1.6 mg/kg
n=3 Participants
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 3, 3.2 mg/kg
n=3 Participants
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 4, 5.4 mg/kg
n=6 Participants
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 5, 6.4 mg/kg
n=6 Participants
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 6, 8.0 mg/kg
n=5 Participants
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
n=48 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
n=49 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
n=19 Participants
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
n=17 Participants
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
n=17 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
n=22 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing NSCLC Tumors
n=58 Participants
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Colorectal Tumors
n=21 Participants
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) of Serum DS-8201a Following First Dose
|
2.18 days
Standard Deviation 0.671
|
3.07 days
Standard Deviation 1.22
|
4.23 days
Standard Deviation 1.24
|
6.03 days
Standard Deviation 0.603
|
7.33 days
Standard Deviation 1.64
|
6.44 days
Standard Deviation 0.793
|
5.52 days
Standard Deviation 1.23
|
6.00 days
Standard Deviation 1.22
|
5.28 days
Standard Deviation 1.49
|
5.79 days
Standard Deviation 1.01
|
6.18 days
Standard Deviation 1.18
|
5.90 days
Standard Deviation 1.57
|
5.61 days
Standard Deviation 1.29
|
5.46 days
Standard Deviation 1.02
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 28 days after the last dose of study drug, up to 3 years 5 monthsPopulation: Safety events were assessed in the Safety Analysis Set. It was prespecified in the protocol that single patients with unique tumor types would be combined into 1 group for the safety analysis. For the safety overview, TEAEs for HER2-expressing NSCLC, Colorectal, and Other Solid Tumors (excluding 1 HER2-low gastric cancer subject who received 5.4 mg/kg) were combined and reported together.
Treatment-emergent adverse events were graded by Common Terminology Criteria for Adverse Events, v4.03.
Outcome measures
| Measure |
Dose Escalation: Cohort 1, 0.8 mg/kg
n=3 Participants
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 2, 1.6 mg/kg
n=3 Participants
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 3, 3.2 mg/kg
n=3 Participants
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 4, 5.4 mg/kg
n=6 Participants
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 5, 6.4 mg/kg
n=6 Participants
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 6, 8.0 mg/kg
n=6 Participants
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
n=50 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
n=66 Participants
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
n=21 Participants
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
n=33 Participants
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
n=19 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
n=25 Participants
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing NSCLC Tumors
n=59 Participants
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overview of Treatment-emergent Adverse Events
Related TEAEs associated with dose interruption
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
15 Participants
|
28 Participants
|
7 Participants
|
11 Participants
|
5 Participants
|
11 Participants
|
17 Participants
|
—
|
—
|
|
Overview of Treatment-emergent Adverse Events
Treatment-emergent adverse events (TEAEs)
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
50 Participants
|
66 Participants
|
20 Participants
|
33 Participants
|
19 Participants
|
25 Participants
|
59 Participants
|
—
|
—
|
|
Overview of Treatment-emergent Adverse Events
Drug-related TEAEs
|
3 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
50 Participants
|
66 Participants
|
20 Participants
|
33 Participants
|
18 Participants
|
25 Participants
|
59 Participants
|
—
|
—
|
|
Overview of Treatment-emergent Adverse Events
TEAEs ≥Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
23 Participants
|
42 Participants
|
11 Participants
|
23 Participants
|
10 Participants
|
20 Participants
|
37 Participants
|
—
|
—
|
|
Overview of Treatment-emergent Adverse Events
Drug-related TEAEs ≥Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
18 Participants
|
37 Participants
|
8 Participants
|
20 Participants
|
8 Participants
|
16 Participants
|
30 Participants
|
—
|
—
|
|
Overview of Treatment-emergent Adverse Events
Serious TEAEs (including AEs ending in death)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
11 Participants
|
17 Participants
|
3 Participants
|
12 Participants
|
4 Participants
|
7 Participants
|
18 Participants
|
—
|
—
|
|
Overview of Treatment-emergent Adverse Events
Drug-related serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
11 Participants
|
2 Participants
|
8 Participants
|
1 Participants
|
3 Participants
|
9 Participants
|
—
|
—
|
|
Overview of Treatment-emergent Adverse Events
TEAEs associated with death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Overview of Treatment-emergent Adverse Events
Drug-related TEAEs associated with death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Overview of Treatment-emergent Adverse Events
TEAEs associated with discontinuation of drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
7 Participants
|
22 Participants
|
0 Participants
|
11 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
|
Overview of Treatment-emergent Adverse Events
Related TEAEs associated with drug discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
21 Participants
|
0 Participants
|
11 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
|
Overview of Treatment-emergent Adverse Events
TEAEs associated with dose reduction
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
18 Participants
|
3 Participants
|
9 Participants
|
5 Participants
|
9 Participants
|
14 Participants
|
—
|
—
|
|
Overview of Treatment-emergent Adverse Events
Drug-related TEAEs associated with dose reduction
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
18 Participants
|
2 Participants
|
9 Participants
|
4 Participants
|
9 Participants
|
13 Participants
|
—
|
—
|
|
Overview of Treatment-emergent Adverse Events
TEAEs associated with dose interruption
|
1 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
21 Participants
|
36 Participants
|
8 Participants
|
13 Participants
|
9 Participants
|
13 Participants
|
22 Participants
|
—
|
—
|
Adverse Events
Dose Escalation: Cohort 1, 0.8 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation: Cohort 2, 1.6 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation: Cohort 3, 3.2 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation: Cohort 4, 5.4 mg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Escalation: Cohort 5, 6.4 mg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Escalation: Cohort 6, 8.0 mg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Serious events: 11 serious events
Other events: 50 other events
Deaths: 3 deaths
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Serious events: 17 serious events
Other events: 66 other events
Deaths: 1 deaths
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Serious events: 12 serious events
Other events: 33 other events
Deaths: 0 deaths
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Serious events: 4 serious events
Other events: 19 other events
Deaths: 1 deaths
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Serious events: 7 serious events
Other events: 25 other events
Deaths: 1 deaths
Dose Expansion: HER2-expressing Other Solid Tumors
Serious events: 18 serious events
Other events: 59 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Dose Escalation: Cohort 1, 0.8 mg/kg
n=3 participants at risk
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 2, 1.6 mg/kg
n=3 participants at risk
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 3, 3.2 mg/kg
n=3 participants at risk
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 4, 5.4 mg/kg
n=6 participants at risk
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 5, 6.4 mg/kg
n=6 participants at risk
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 6, 8.0 mg/kg
n=6 participants at risk
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
n=50 participants at risk
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
n=66 participants at risk
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
n=21 participants at risk
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
n=33 participants at risk
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
n=19 participants at risk
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
n=25 participants at risk
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Other Solid Tumors
n=59 participants at risk
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.5%
2/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Peritonitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.1%
3/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.1%
3/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.0%
3/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
3/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
4/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Small intestine obstruction
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Gastrointestinal mucosa hyperaemia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
2/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Musculoskeletal and connective tissue disorders
Scleroderma-like reaction
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
General disorders
Disease progression
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
General disorders
Malaise
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
General disorders
Pain
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
4/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Troponin increased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Surgical and medical procedures
Central venous catheterisation
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
Other adverse events
| Measure |
Dose Escalation: Cohort 1, 0.8 mg/kg
n=3 participants at risk
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 2, 1.6 mg/kg
n=3 participants at risk
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 3, 3.2 mg/kg
n=3 participants at risk
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 4, 5.4 mg/kg
n=6 participants at risk
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 5, 6.4 mg/kg
n=6 participants at risk
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Escalation: Cohort 6, 8.0 mg/kg
n=6 participants at risk
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
n=50 participants at risk
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
n=66 participants at risk
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
n=21 participants at risk
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
n=33 participants at risk
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
n=19 participants at risk
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
n=25 participants at risk
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
Dose Expansion: HER2-expressing Other Solid Tumors
n=59 participants at risk
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.0%
5/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
13.6%
9/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.1%
4/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.0%
3/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.2%
6/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
18.0%
9/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.6%
7/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.1%
4/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.8%
4/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.0%
5/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
6/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
2/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
4/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.5%
3/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.5%
2/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.0%
3/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.5%
3/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.5%
3/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
2/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.1%
3/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.5%
3/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
3/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
2/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
50.0%
3/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
46.0%
23/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
45.5%
30/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
7/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
42.4%
14/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
21.1%
4/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
56.0%
14/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
39.0%
23/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
3/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.1%
3/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
66.7%
4/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
66.7%
4/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
46.0%
23/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
71.2%
47/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
7/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
60.6%
20/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
42.1%
8/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
88.0%
22/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
59.3%
35/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
18.0%
9/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
19.7%
13/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
18.2%
6/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
21.1%
4/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.0%
3/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
15.3%
9/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.0%
5/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
13.6%
9/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.5%
2/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
18.2%
6/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.0%
4/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.5%
5/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
13.6%
9/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.0%
3/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.5%
5/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.5%
3/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
11.9%
7/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.5%
2/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
6/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
3/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
2/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.8%
4/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.5%
2/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
4/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
21.2%
14/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
14.3%
3/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.5%
2/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
20.0%
5/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
15.3%
9/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.0%
8/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
11/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.1%
4/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
21.1%
4/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.8%
4/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.0%
8/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
7.6%
5/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
14.3%
3/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.1%
4/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
13.6%
8/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
6/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
3/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.5%
2/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.1%
3/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
4/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.5%
3/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.5%
2/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.0%
6/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.1%
8/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.5%
2/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Eye disorders
Keratitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
7.6%
5/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
2/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.5%
3/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Eye disorders
Retinal tear
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.5%
2/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.5%
2/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
4/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.1%
4/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
7.6%
5/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
4/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
28.0%
14/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
18.2%
12/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.5%
2/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
15.2%
5/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.5%
2/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.2%
6/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.0%
8/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
6/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.5%
2/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.0%
3/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
13.6%
8/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
15.2%
10/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
21.2%
7/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.0%
3/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.5%
5/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
14.0%
7/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.1%
8/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
14.3%
3/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
15.2%
5/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.8%
4/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
6/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
3/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
2/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
11.9%
7/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.5%
3/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
3/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.5%
3/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.5%
2/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
3/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.1%
3/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.5%
3/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
4/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
4/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
4/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
66.7%
2/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
100.0%
6/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
66.7%
4/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
66.7%
4/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
86.0%
43/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
78.8%
52/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
71.4%
15/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
78.8%
26/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
63.2%
12/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
76.0%
19/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
74.6%
44/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
66.7%
2/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
66.7%
4/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
56.0%
28/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
53.0%
35/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
47.6%
10/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
42.4%
14/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
15.8%
3/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
32.0%
8/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
52.5%
31/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
50.0%
3/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
36.0%
18/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
42.4%
28/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
42.9%
9/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
48.5%
16/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
15.8%
3/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
20.0%
5/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
32.2%
19/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
66.7%
4/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
36.0%
18/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
45.5%
30/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
7/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
42.4%
14/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
26.3%
5/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
28.0%
7/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
27.1%
16/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
14.0%
7/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
27.3%
18/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
19.0%
4/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
39.4%
13/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.0%
4/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.9%
10/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
14.0%
7/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
13.6%
9/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.2%
6/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
14.0%
7/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
13.6%
9/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.5%
2/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
50.0%
3/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.1%
8/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
7.6%
5/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.5%
3/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
14.3%
3/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.1%
3/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
4/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
4/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
3/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.5%
2/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.0%
3/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
2/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
50.0%
3/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
50.0%
3/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
38.0%
19/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
68.2%
45/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
28.6%
6/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
54.5%
18/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
21.1%
4/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.0%
4/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.9%
20/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.0%
5/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.1%
8/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.1%
4/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.2%
6/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.0%
6/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.1%
8/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
15.2%
5/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
6/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.1%
3/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
4/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
4/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.5%
2/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.8%
4/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
4/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.0%
5/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
6/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.5%
2/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
2/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.8%
4/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
6/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
4/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.1%
4/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.1%
3/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
7.6%
5/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
General disorders
Fatigue
|
100.0%
3/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
50.0%
3/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
66.7%
4/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
48.0%
24/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
48.5%
32/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
52.4%
11/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
27.3%
9/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
21.1%
4/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.0%
3/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
35.6%
21/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
General disorders
Malaise
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.0%
6/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
28.8%
19/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.5%
2/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
39.4%
13/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
15.8%
3/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
20.0%
5/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
22.0%
13/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
20.0%
10/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
27.3%
18/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
27.3%
9/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
15.8%
3/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
32.0%
8/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
15.3%
9/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
20.0%
10/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
15.2%
10/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
19.0%
4/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.1%
4/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.5%
2/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.2%
6/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
General disorders
Oedema
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.6%
7/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.0%
4/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
General disorders
Chills
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.0%
6/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
7.6%
5/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
General disorders
Influenza-like illness
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
7.6%
5/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
General disorders
Pain
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
General disorders
Asthenia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
4/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.5%
2/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
66.7%
4/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
50.0%
3/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
50.0%
3/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
30.0%
15/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
36.4%
24/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
14.3%
3/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
42.4%
14/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
26.3%
5/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
48.0%
12/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
37.3%
22/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
66.7%
4/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
24.0%
12/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
37.9%
25/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
14.3%
3/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
39.4%
13/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.5%
2/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
48.0%
12/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
35.6%
21/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
50.0%
3/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
18.0%
9/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
22/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
19.0%
4/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
39.4%
13/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
15.8%
3/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
44.0%
11/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
28.8%
17/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
18.0%
9/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
34.8%
23/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
14.3%
3/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
30.3%
10/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.0%
3/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
20.3%
12/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
14.0%
7/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
25.8%
17/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
21.2%
7/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.0%
3/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
13.6%
8/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.0%
5/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
13.6%
9/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
14.3%
3/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
15.2%
5/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.5%
2/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
18.6%
11/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.0%
5/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.6%
7/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.1%
4/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.5%
2/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
11.9%
7/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Electrocardiogram QT prolonged
|
66.7%
2/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.0%
5/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
6/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
19.0%
4/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
2/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
12.1%
8/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.0%
4/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
3/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.0%
4/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.8%
4/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
10.6%
7/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Weight increased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
9.1%
6/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.0%
3/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.5%
5/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Protein total decreased
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
8.0%
4/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.5%
3/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Injury, poisoning and procedural complications
Infusion-related reaction
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.3%
1/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Ear infection
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour-associated fever
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Blood and lymphatic system disorders
Cold type haemolytic anaemia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Eye disorders
Corneal disorder
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Eye disorders
Uveitis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
1/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.5%
3/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.8%
1/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.5%
3/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
6.1%
2/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
5.1%
3/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.4%
2/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
4.0%
2/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
2/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
3.0%
1/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Investigations
Blood creatinine phosphokinase increased
|
33.3%
1/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.5%
1/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/3 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
16.7%
1/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/6 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
2.0%
1/50 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/66 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/21 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/33 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/19 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
0.00%
0/25 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
1.7%
1/59 • Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
|
Additional Information
Contact for Clinical Trial Information
Daiichi Sankyo, Inc.
Phone: 1-908-992-6400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place