Trial Outcomes & Findings for A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201) (NCT NCT05267470)
NCT ID: NCT05267470
Last Updated: 2025-03-25
Results Overview
DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and included the below if considered by the investigator to be related to study drug, excluding toxicities related to disease progression or intercurrent illness: Grade 3 thrombocytopenia for \> 7 days or with Grade \> 2 bleeding, vomiting/diarrhea for \> 3 days, fatigue; Grade ≥ 3 febrile neutropenia, nausea for \> 3 days; Grade 4 neutropenia, thrombocytopenia, anemia, ophthalmologic AE, laboratory value, vomiting/diarrhea; Grade 5 toxicity (death not due to disease progression). CTCAE Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, and Grade 5 results in death.
TERMINATED
PHASE1
74 participants
Day 1 to Day 21 of Cycle 1 (each cycle was 21 days)
2025-03-25
Participant Flow
A total of 74 participants were enrolled across 8 countries from March 2022 and the last participant last visit was in May 2024.
The study consisted of 4 Parts: * Part 1: Combination dose exploration with docetaxel * Part 2: Combination dose expansion with docetaxel * Part 3: Monotherapy * Part 4: Combination with carboplatin, paclitaxel or nab-paclitaxel, and pembrolizumab. The planned dose levels were dose level 1 (lower) and dose level 2 (higher).
Participant milestones
| Measure |
Part 1: Bemarituzumab Dose 1 With Docetaxel
Participants received multiple intravenous (IV) doses of bemarituzumab dose level 1 and IV docetaxel (cycle length = 21 days).
|
Part 1: Bemarituzumab Dose 2 With Docetaxel
Participants received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 2: Bemarituzumab Dose 2 With Docetaxel
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 3: Bemarituzumab Dose 1
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 1 (cycle length = 14 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
9
|
29
|
28
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
29
|
28
|
4
|
Reasons for withdrawal
| Measure |
Part 1: Bemarituzumab Dose 1 With Docetaxel
Participants received multiple intravenous (IV) doses of bemarituzumab dose level 1 and IV docetaxel (cycle length = 21 days).
|
Part 1: Bemarituzumab Dose 2 With Docetaxel
Participants received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 2: Bemarituzumab Dose 2 With Docetaxel
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 3: Bemarituzumab Dose 1
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 1 (cycle length = 14 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
|---|---|---|---|---|---|
|
Overall Study
Decision by sponsor
|
0
|
3
|
19
|
7
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
2
|
0
|
|
Overall Study
Death
|
3
|
5
|
8
|
18
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201)
Baseline characteristics by cohort
| Measure |
Part 1: Bemarituzumab Dose 1 With Docetaxel
n=4 Participants
Participants received multiple IV doses of bemarituzumab dose level 1 and IV docetaxel (cycle length = 21 days).
|
Part 1: Bemarituzumab Dose 2 With Docetaxel
n=9 Participants
Participants received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 2: Bemarituzumab Dose 2 With Docetaxel
n=29 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 3: Bemarituzumab Dose 1
n=28 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 1 (cycle length = 14 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=4 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
65.9 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
65.3 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
63.0 years
STANDARD_DEVIATION 7.9 • n=21 Participants
|
64.3 years
STANDARD_DEVIATION 7.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
62 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
71 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 21 of Cycle 1 (each cycle was 21 days)Population: The safety analysis set included all participants who received at least one dose of bemarituzumab.
DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and included the below if considered by the investigator to be related to study drug, excluding toxicities related to disease progression or intercurrent illness: Grade 3 thrombocytopenia for \> 7 days or with Grade \> 2 bleeding, vomiting/diarrhea for \> 3 days, fatigue; Grade ≥ 3 febrile neutropenia, nausea for \> 3 days; Grade 4 neutropenia, thrombocytopenia, anemia, ophthalmologic AE, laboratory value, vomiting/diarrhea; Grade 5 toxicity (death not due to disease progression). CTCAE Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, and Grade 5 results in death.
Outcome measures
| Measure |
Part 1: Bemarituzumab Dose 1 With Docetaxel
n=4 Participants
Participants received multiple IV doses of bemarituzumab dose level 1 and IV docetaxel (cycle length = 21 days).
|
Part 1: Bemarituzumab Dose 2 With Docetaxel
n=9 Participants
Participants received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=4 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
Part 3: Bemarituzumab Dose 1
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 1 (cycle length = 14 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT): Parts 1 and 4
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.Population: The safety analysis set included all participants who received at least one dose of bemarituzumab.
An AE was defined as any untoward medical occurrence in a clinical trial participants. TEAEs were any AE that started on or after receiving the first dose of investigational product and up to 28 days after the last dose of investigational product or the end of study date, whichever is earlier. Treatment-related TEAEs were those considered possibly related to study treatment by the investigator. Any clinically significant changes in electrocardiograms, vital signs, physical examination with a neurological assessment, clinical laboratory tests, and visual acuity were recorded as TEAEs. A serious TEAE resulted in death, was immediately life threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event. AEs of special interest (AESIs) were ocular events of any CTCAE grade or seriousness occurring up to 100 days after the last dose of bemarituzumab.
Outcome measures
| Measure |
Part 1: Bemarituzumab Dose 1 With Docetaxel
n=4 Participants
Participants received multiple IV doses of bemarituzumab dose level 1 and IV docetaxel (cycle length = 21 days).
|
Part 1: Bemarituzumab Dose 2 With Docetaxel
n=9 Participants
Participants received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=29 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
Part 3: Bemarituzumab Dose 1
n=28 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 1 (cycle length = 14 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=4 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Any treatment-related SAE
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Any TEAE
|
4 Participants
|
9 Participants
|
29 Participants
|
25 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Any SAE
|
4 Participants
|
5 Participants
|
16 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Any treatment-related TEAE
|
3 Participants
|
9 Participants
|
21 Participants
|
16 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Any AESI
|
2 Participants
|
6 Participants
|
17 Participants
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Parts 1, 2, 3, and 4: Cycles 1 and 2 pre-dose, 0.25, 3, 6, 24, 72, 168, 336, 504 (except Part 3) hours post-dosePopulation: The PK analysis set included all participants who received at least one dose of bemarituzumab and had at least one PK sample collected. Participants with data available at each timepoint are presented.
Bemarituzumab serum concentrations with values below the limit of quantification were set to zero for analysis. Pharmacokinetic (PK) parameters were determined from the time concentration profile using noncompartmental analysis.
Outcome measures
| Measure |
Part 1: Bemarituzumab Dose 1 With Docetaxel
n=4 Participants
Participants received multiple IV doses of bemarituzumab dose level 1 and IV docetaxel (cycle length = 21 days).
|
Part 1: Bemarituzumab Dose 2 With Docetaxel
n=9 Participants
Participants received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=29 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
Part 3: Bemarituzumab Dose 1
n=25 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 1 (cycle length = 14 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=3 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
|---|---|---|---|---|---|
|
Area Under the Serum Drug Concentration-time Curve From Time 0 to End of Dosing Interval (AUCtau) of Bemarituzumab
Cycle 1
|
3370 day*mcg/mL
Interval 2400.0 to 4880.0
|
5300 day*mcg/mL
Interval 3830.0 to 6870.0
|
3920 day*mcg/mL
Interval 2290.0 to 6470.0
|
2800 day*mcg/mL
Interval 1360.0 to 4820.0
|
3020 day*mcg/mL
Interval 2000.0 to 3270.0
|
|
Area Under the Serum Drug Concentration-time Curve From Time 0 to End of Dosing Interval (AUCtau) of Bemarituzumab
Cycle 2
|
2610 day*mcg/mL
Interval 2160.0 to 4810.0
|
4850 day*mcg/mL
Interval 1190.0 to 7290.0
|
4000 day*mcg/mL
Interval 1200.0 to 10300.0
|
3580 day*mcg/mL
Interval 1880.0 to 5970.0
|
2340 day*mcg/mL
Interval 1470.0 to 3200.0
|
SECONDARY outcome
Timeframe: Parts 1, 2, 3, and 4: Cycles 1 and 2 pre-dose, 0.25, 3, 6, 24, 72, 168, 336, 504 (except Part 3) hours post-dosePopulation: The PK analysis set included all participants who received at least one dose of bemarituzumab and had at least one PK sample collected. Participants with data available at each timepoint are presented.
Bemarituzumab serum concentrations with values below the limit of quantification were set to zero for analysis. PK parameters were determined from the time concentration profile using noncompartmental analysis.
Outcome measures
| Measure |
Part 1: Bemarituzumab Dose 1 With Docetaxel
n=4 Participants
Participants received multiple IV doses of bemarituzumab dose level 1 and IV docetaxel (cycle length = 21 days).
|
Part 1: Bemarituzumab Dose 2 With Docetaxel
n=9 Participants
Participants received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=29 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
Part 3: Bemarituzumab Dose 1
n=25 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 1 (cycle length = 14 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=3 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Bemarituzumab
Cycle 1
|
599 mcg/mL
Interval 457.0 to 751.0
|
746 mcg/mL
Interval 627.0 to 896.0
|
646 mcg/mL
Interval 338.0 to 956.0
|
398 mcg/mL
Interval 238.0 to 1430.0
|
561 mcg/mL
Interval 463.0 to 564.0
|
|
Maximum Observed Serum Concentration (Cmax) of Bemarituzumab
Cycle 2
|
379 mcg/mL
Interval 358.0 to 599.0
|
715 mcg/mL
Interval 595.0 to 910.0
|
601 mcg/mL
Interval 314.0 to 845.0
|
532 mcg/mL
Interval 314.0 to 811.0
|
322 mcg/mL
Interval 235.0 to 409.0
|
SECONDARY outcome
Timeframe: Pre-dose Cycle 2 Day 1 and Cycle 3 day 1Population: The PK analysis set included all participants who received at least one dose of bemarituzumab and had at least one PK sample collected. Participants with data available at each timepoint are presented.
Bemarituzumab serum concentrations with values below the limit of quantification were set to zero for analysis. PK parameters were determined from the time concentration profile using noncompartmental analysis.
Outcome measures
| Measure |
Part 1: Bemarituzumab Dose 1 With Docetaxel
n=3 Participants
Participants received multiple IV doses of bemarituzumab dose level 1 and IV docetaxel (cycle length = 21 days).
|
Part 1: Bemarituzumab Dose 2 With Docetaxel
n=9 Participants
Participants received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=21 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
Part 3: Bemarituzumab Dose 1
n=26 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 1 (cycle length = 14 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=3 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
|---|---|---|---|---|---|
|
Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab
Pre-dose Cycle 3 Day 1
|
79.1 mcg/mL
Interval 33.9 to 112.0
|
149 mcg/mL
Interval 45.0 to 201.0
|
111 mcg/mL
Interval 30.6 to 169.0
|
140 mcg/mL
Interval 29.3 to 271.0
|
69.2 mcg/mL
Interval 69.2 to 69.2
|
|
Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab
Pre-dose Cycle 2 Day 1
|
51.5 mcg/mL
Interval 25.8 to 96.6
|
93.7 mcg/mL
Interval 40.2 to 175.0
|
88.9 mcg/mL
Interval 50.5 to 154.0
|
147 mcg/mL
Interval 10.1 to 554.0
|
29.9 mcg/mL
Interval 25.3 to 32.5
|
SECONDARY outcome
Timeframe: Every 6 (+/- 1) weeks from the first dose of bemarituzumab (cycle 1 day 1) up to week 54, then every 12 (+/- 2 weeks), up to the end of the long term follow-up (LTFU) period (median time on study was approximately 21 weeks)Population: The safety analysis set included all participants who received at least one dose of bemarituzumab.
OR was defined as the best overall response of confirmed complete response (CR) or confirmed partial response (PR) as defined by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \<10 mm. All lymph nodes must have been non-pathological in size (\< 10 mm). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Part 1: Bemarituzumab Dose 1 With Docetaxel
n=4 Participants
Participants received multiple IV doses of bemarituzumab dose level 1 and IV docetaxel (cycle length = 21 days).
|
Part 1: Bemarituzumab Dose 2 With Docetaxel
n=9 Participants
Participants received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=29 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
Part 3: Bemarituzumab Dose 1
n=28 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 1 (cycle length = 14 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=4 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an Objective Response (OR)
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
10.3 percentage of participants
Interval 2.2 to 27.4
|
0.0 percentage of participants
Interval 0.0 to 12.3
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
SECONDARY outcome
Timeframe: Every 6 (+/- 1) weeks from the first dose of bemarituzumab (cycle 1 day 1) up to week 54, then every 12 (+/- 2 weeks), up to the end of the LTFU period (median time on study was approximately 21 weeks)Population: The safety analysis set included all participants who received at least one dose of bemarituzumab. Only participants who had achieved OR were evaluated for DOR.
DOR was defined as the time from the first documentation of OR (determined by the investigator per RECIST v1.1) until first documentation of disease progression or death due to any cause, whichever occurred first. DOR was censored at the last evaluable post-baseline tumor assessment prior to subsequent anticancer therapy; otherwise, at date of first documentation of OR (i.e., assigned a one-day interval).
Outcome measures
| Measure |
Part 1: Bemarituzumab Dose 1 With Docetaxel
Participants received multiple IV doses of bemarituzumab dose level 1 and IV docetaxel (cycle length = 21 days).
|
Part 1: Bemarituzumab Dose 2 With Docetaxel
n=2 Participants
Participants received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=3 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
Part 3: Bemarituzumab Dose 1
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 1 (cycle length = 14 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=1 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
—
|
5.5 months
Interval 2.8 to
Upper confidence interval (CI) was not calculable due to insufficient event data occurring above the median.
|
2.8 months
Interval 2.8 to
Upper CI was not calculable due to insufficient event data occurring above the median.
|
—
|
4.5 months
CIs were not calculable due to only 1 participant achieving OR.
|
SECONDARY outcome
Timeframe: Every 6 (+/- 1) weeks from the first dose of bemarituzumab (cycle 1 day 1) up to week 54, then every 12 (+/- 2 weeks), up to the end of the LTFU period (median time on study was approximately 21 weeks)Population: The safety analysis set included all participants who received at least one dose of bemarituzumab.
DCR was defined as the percentage of participants documented to have a CR, PR or stable disease (SD) per RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \<10 mm. All lymph nodes must have been non-pathological in size (\< 10 mm). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5 mm. Unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Part 1: Bemarituzumab Dose 1 With Docetaxel
n=4 Participants
Participants received multiple IV doses of bemarituzumab dose level 1 and IV docetaxel (cycle length = 21 days).
|
Part 1: Bemarituzumab Dose 2 With Docetaxel
n=9 Participants
Participants received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=29 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
Part 3: Bemarituzumab Dose 1
n=28 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 1 (cycle length = 14 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=4 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
65.5 percentage of participants
Interval 45.7 to 82.1
|
53.6 percentage of participants
Interval 33.9 to 72.5
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
SECONDARY outcome
Timeframe: Participants completed the LTFU for survival every 3 months ± 1 month after the safety follow-up visit (at 28 days after the last dose of bemarituzumab), up to the end of the study. Median time on study was approximately 21 weeksPopulation: The safety analysis set included all participants who received at least one dose of bemarituzumab.
PFS was defined as the time from date of first dose of investigational product until the first documentation of radiologic disease progression or death due to any cause, whichever occurred first, in the absence of subsequent anticancer therapy. PFS was censored at the last evaluable post-baseline tumor assessment prior to subsequent anticancer therapy; otherwise, at first dose of investigational product. Progression was based on RECIST v1.1 criteria. PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5 mm. Unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Part 1: Bemarituzumab Dose 1 With Docetaxel
n=4 Participants
Participants received multiple IV doses of bemarituzumab dose level 1 and IV docetaxel (cycle length = 21 days).
|
Part 1: Bemarituzumab Dose 2 With Docetaxel
n=9 Participants
Participants received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=29 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
Part 3: Bemarituzumab Dose 1
n=28 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 1 (cycle length = 14 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=4 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
4.2 months
Interval 1.2 to
Upper CI was not calculable due to insufficient event data occurring above the median.
|
4.2 months
Interval 1.4 to 10.8
|
4.0 months
Interval 1.4 to 4.4
|
1.8 months
Interval 1.3 to 2.6
|
5.6 months
Interval 1.3 to
Upper CI was not calculable due to insufficient event data occurring above the median.
|
SECONDARY outcome
Timeframe: Participants completed the LTFU for survival every 3 months ± 1 month after the safety follow-up visit (at 28 days after the last dose of bemarituzumab), up to the end of the study. Median time on study was approximately 21 weeksPopulation: The safety analysis set included all participants who received at least one dose of bemarituzumab.
OS was defined as the time from the date of first dose of investigational product until event of death due to any cause through the analysis cutoff date. Participants still alive were censored at the date last known to be alive through the analysis cutoff date.
Outcome measures
| Measure |
Part 1: Bemarituzumab Dose 1 With Docetaxel
n=4 Participants
Participants received multiple IV doses of bemarituzumab dose level 1 and IV docetaxel (cycle length = 21 days).
|
Part 1: Bemarituzumab Dose 2 With Docetaxel
n=9 Participants
Participants received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=29 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
Part 3: Bemarituzumab Dose 1
n=28 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 1 (cycle length = 14 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=4 Participants
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
|---|---|---|---|---|---|
|
Overall Survival (OS)
|
6.0 months
Interval 5.6 to
Upper CI was not calculable due to insufficient event data occurring above the median.
|
12.8 months
Interval 3.3 to
Upper CI was not calculable due to insufficient event data occurring above the median.
|
NA months
Interval 9.1 to
Median and upper CI were not calculable due to fewer than 50% events.
|
5.4 months
Interval 2.8 to 8.0
|
NA months
Interval 3.5 to
Median and upper CI were not calculable due to fewer than 50% events.
|
Adverse Events
Part 1: Bemarituzumab Dose 1 With Docetaxel
Part 1: Bemarituzumab Dose 2 With Docetaxel
Part 2: Bemarituzumab Dose 2 With Docetaxel
Part 3: Bemarituzumab Dose 1
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
Serious adverse events
| Measure |
Part 1: Bemarituzumab Dose 1 With Docetaxel
n=4 participants at risk
Participants received multiple IV doses of bemarituzumab dose level 1 and IV docetaxel (cycle length = 21 days).
|
Part 1: Bemarituzumab Dose 2 With Docetaxel
n=9 participants at risk
Participants received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 2: Bemarituzumab Dose 2 With Docetaxel
n=29 participants at risk
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 3: Bemarituzumab Dose 1
n=28 participants at risk
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 1 (cycle length = 14 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=4 participants at risk
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
13.8%
4/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Cardiac disorders
Cardiac tamponade
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Cardiac disorders
Pericarditis malignant
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Corneal epithelium defect
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
General disorders
Asthenia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
General disorders
General physical health deterioration
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Hepatobiliary disorders
Cholecystitis
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Infections and infestations
COVID-19
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
10.3%
3/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Nervous system disorders
Cerebral disorder
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Vascular disorders
Shock
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
Other adverse events
| Measure |
Part 1: Bemarituzumab Dose 1 With Docetaxel
n=4 participants at risk
Participants received multiple IV doses of bemarituzumab dose level 1 and IV docetaxel (cycle length = 21 days).
|
Part 1: Bemarituzumab Dose 2 With Docetaxel
n=9 participants at risk
Participants received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 2: Bemarituzumab Dose 2 With Docetaxel
n=29 participants at risk
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 and IV docetaxel (cycle length = 21 days).
|
Part 3: Bemarituzumab Dose 1
n=28 participants at risk
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 1 (cycle length = 14 days).
|
Part 4: Bemarituzumab Dose 2 First-line Combination Therapy
n=4 participants at risk
Participants who had an overexpression of FGFR2b received multiple IV doses of bemarituzumab dose level 2 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel (cycle length = 21 days).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
2/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
20.7%
6/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
2/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
17.2%
5/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Acute macular neuroretinopathy
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Blepharitis
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
17.2%
5/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
10.7%
3/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Cataract
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Corneal disorder
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
33.3%
3/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
7.1%
2/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Corneal epithelium defect
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
10.3%
3/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Corneal opacity
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Dry eye
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
14.3%
4/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Keratitis
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
10.3%
3/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Keratopathy
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
22.2%
2/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
34.5%
10/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
14.3%
4/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Limbal stem cell deficiency
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
13.8%
4/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Meibomian gland dysfunction
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Retinal drusen
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Eye disorders
Visual acuity reduced
|
75.0%
3/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
66.7%
6/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
51.7%
15/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
32.1%
9/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
50.0%
2/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
22.2%
2/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
7.1%
2/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
22.2%
2/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
27.6%
8/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
14.3%
4/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Gastrointestinal disorders
Haemorrhoids
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
14.3%
4/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
22.2%
2/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
13.8%
4/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
7.1%
2/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
General disorders
Asthenia
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
34.5%
10/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
7.1%
2/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
General disorders
Fatigue
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
22.2%
2/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
10.7%
3/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
General disorders
Generalised oedema
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
General disorders
Malaise
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
13.8%
4/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
7.1%
2/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
10.7%
3/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Hepatobiliary disorders
Liver injury
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
7.1%
2/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Infections and infestations
Paronychia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
22.2%
2/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
10.7%
3/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
22.2%
2/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
27.6%
8/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
14.3%
4/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
10.7%
3/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
7.1%
2/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
7.1%
2/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
7.1%
2/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
7.1%
2/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
7.1%
2/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Nervous system disorders
Dysgeusia
|
50.0%
2/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
10.7%
3/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
7.1%
2/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
33.3%
3/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
10.3%
3/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
10.7%
3/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
21.4%
6/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
22.2%
2/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
7.1%
2/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
7.1%
2/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
22.2%
2/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
10.3%
3/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
7.1%
2/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
7.1%
2/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.4%
1/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
11.1%
1/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/9 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
6.9%
2/29 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
3.6%
1/28 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
0.00%
0/4 • For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
The safety analysis set included all participants who received at least one dose of bemarituzumab.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER