Trial Outcomes & Findings for Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer (NCT NCT02980341)
NCT ID: NCT02980341
Last Updated: 2024-10-30
Results Overview
AEs will be collected systematically from signing of the informed consent form (ICF) through 28 days after last dose
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
182 participants
Primary outcome timeframe
Baseline up to 28 days post last dose, up to approximately 9 months
Results posted on
2024-10-30
Participant Flow
A total of 182 participants who met all inclusion criteria and no exclusion criteria received at least 1 dose of study treatment.
Participant milestones
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation
STARTED
|
3
|
3
|
15
|
15
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
NOT COMPLETED
|
3
|
3
|
15
|
15
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Finding
STARTED
|
0
|
0
|
0
|
0
|
0
|
12
|
12
|
0
|
0
|
0
|
0
|
|
Dose Finding
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Finding
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
12
|
12
|
0
|
0
|
0
|
0
|
|
Dose Expansion
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
33
|
31
|
21
|
31
|
|
Dose Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
33
|
31
|
21
|
31
|
Reasons for withdrawal
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation
Progressive disease per RECIST v1.1
|
3
|
3
|
11
|
10
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
Clinical progression
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
Adverse Event
|
0
|
0
|
1
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
Due to side effect management of chemotherapy
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
Due to investigator's decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Finding
Progressive disease per RECIST v1.1
|
0
|
0
|
0
|
0
|
0
|
8
|
11
|
0
|
0
|
0
|
0
|
|
Dose Finding
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Dose Finding
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Dose Expansion
Progressive disease per RECIST v1.1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
23
|
24
|
17
|
23
|
|
Dose Expansion
Clinical progression
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
3
|
1
|
4
|
|
Dose Expansion
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
1
|
3
|
|
Dose Expansion
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
|
Dose Expansion
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
0
|
|
Dose Expansion
Due to investigator's decision considering patient's liver condition
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Dose Expansion
Due to investigator's decision due to patient's general condition
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Dose Expansion
Due to investigator's decision because patient was a candidate for surgery
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Dose Expansion
Patient withdrew consent following 50 treatment cycles
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
n=6 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
n=12 Participants
Participants who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
n=12 Participants
Participants who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
n=33 Participants
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
n=31 Participants
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
n=21 Participants
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
n=31 Participants
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 10.41 • n=99 Participants
|
62.3 years
STANDARD_DEVIATION 22.74 • n=107 Participants
|
52.1 years
STANDARD_DEVIATION 13.38 • n=206 Participants
|
58.7 years
STANDARD_DEVIATION 11.76 • n=7 Participants
|
50.2 years
STANDARD_DEVIATION 8.45 • n=31 Participants
|
51.8 years
STANDARD_DEVIATION 13.79 • n=30 Participants
|
50.7 years
STANDARD_DEVIATION 11.92 • n=3 Participants
|
56.0 years
STANDARD_DEVIATION 11.95 • n=6 Participants
|
56.9 years
STANDARD_DEVIATION 11.04 • n=114 Participants
|
55.4 years
STANDARD_DEVIATION 12.92
|
58.0 years
STANDARD_DEVIATION 13.73 • n=19 Participants
|
55.6 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
12 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
33 Participants
n=6 Participants
|
31 Participants
n=114 Participants
|
21 Participants
|
31 Participants
n=19 Participants
|
182 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
11 Participants
n=6 Participants
|
11 Participants
n=114 Participants
|
6 Participants
|
6 Participants
n=19 Participants
|
34 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black of African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
12 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
19 Participants
n=6 Participants
|
18 Participants
n=114 Participants
|
15 Participants
|
24 Participants
n=19 Participants
|
142 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 28 days post last dose, up to approximately 9 monthsPopulation: Adverse events are reported from the Safety Analysis Set.
AEs will be collected systematically from signing of the informed consent form (ICF) through 28 days after last dose
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
n=6 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
n=12 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
n=12 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
n=33 Participants
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
n=31 Participants
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
n=21 Participants
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
n=31 Participants
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)
Any TEAE associated with death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)
Any TEAE associated with dose interruption
|
1 Participants
|
2 Participants
|
7 Participants
|
12 Participants
|
3 Participants
|
8 Participants
|
6 Participants
|
16 Participants
|
15 Participants
|
10 Participants
|
20 Participants
|
|
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)
Any TEAE
|
3 Participants
|
3 Participants
|
15 Participants
|
15 Participants
|
6 Participants
|
12 Participants
|
12 Participants
|
32 Participants
|
31 Participants
|
21 Participants
|
31 Participants
|
|
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)
Any TEAE Grade ≥3
|
2 Participants
|
1 Participants
|
11 Participants
|
13 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
20 Participants
|
24 Participants
|
16 Participants
|
27 Participants
|
|
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)
Any TEAE associated with study treatment discontinuation
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)
Any TEAE associated with dose reduction
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
9 Participants
|
2 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: From screening until disease progresses, up to approximately 9 monthsPopulation: Best overall tumor response was assessed in the Full Analysis Set.
CR was defined as a disappearance of all target and non-target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target and non-target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target and non-target lesions. Objective response rate is the number of patients with confirmed complete response and confirmed partial response.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
n=6 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
n=12 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
n=12 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
n=33 Participants
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
n=31 Participants
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
n=21 Participants
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
n=31 Participants
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Best Overall Tumor Response Using Blinded Independent Central Review Based on Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
Complete response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Tumor Response Using Blinded Independent Central Review Based on Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
Stable disease (SD)/Non-CR/Non-PD
|
2 Participants
|
2 Participants
|
7 Participants
|
8 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
19 Participants
|
17 Participants
|
7 Participants
|
21 Participants
|
|
Number of Participants With Best Overall Tumor Response Using Blinded Independent Central Review Based on Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
Progressive disease (PD)
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Best Overall Tumor Response Using Blinded Independent Central Review Based on Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
Partial response (PR)
|
0 Participants
|
1 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
11 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Best Overall Tumor Response Using Blinded Independent Central Review Based on Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
Nonevaluable (NE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Best Overall Tumor Response Using Blinded Independent Central Review Based on Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
Objective response rate (ORR)
|
0 Participants
|
1 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
11 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were analyzed in the Pharmacokinetic Analysis Set.
The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
n=6 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Part: Area Under the Serum Concentration Time Curve (AUC) of Anti-HER3-ac-DXd
AUClast, Cycle 1
|
2470 ng*d/mL
Standard Deviation 435
|
4420 ng*d/mL
Standard Deviation 1020
|
8690 ng*d/mL
Standard Deviation 1070
|
13000 ng*d/mL
Standard Deviation 3310
|
16700 ng*d/mL
Standard Deviation 4170
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Area Under the Serum Concentration Time Curve (AUC) of Anti-HER3-ac-DXd
AUClast, Cycle 3
|
2400 ng*d/mL
|
5920 ng*d/mL
Standard Deviation 1070
|
13800 ng*d/mL
Standard Deviation 3730
|
20500 ng*d/mL
Standard Deviation 4070
|
27100 ng*d/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Area Under the Serum Concentration Time Curve (AUC) of Anti-HER3-ac-DXd
AUCtau, Cycle 1
|
2470 ng*d/mL
Standard Deviation 438
|
4420 ng*d/mL
Standard Deviation 1020
|
8600 ng*d/mL
Standard Deviation 1870
|
13600 ng*d/mL
Standard Deviation 3020
|
16700 ng*d/mL
Standard Deviation 4170
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Area Under the Serum Concentration Time Curve (AUC) of Anti-HER3-ac-DXd
AUCtau, Cycle 3
|
2420 ng*d/mL
|
5900 ng*d/mL
Standard Deviation 2050
|
13700 ng*d/mL
Standard Deviation 3700
|
20300 ng*d/mL
Standard Deviation 3200
|
21000 ng*d/mL
Standard Deviation 5420
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Area Under the Serum Concentration Time Curve (AUC) of Anti-HER3-ac-DXd
AUCinf, Cycle 1
|
2490 ng*d/mL
Standard Deviation 440
|
4470 ng*d/mL
Standard Deviation 1060
|
8990 ng*d/mL
Standard Deviation 2230
|
14600 ng*d/mL
Standard Deviation 3510
|
18300 ng*d/mL
Standard Deviation 4920
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 4, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.
The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=11 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=12 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Finding Part: AUC of Anti-HER3-ac-DXd
AUClast, Cycle 1
|
5540 ng*d/mL
Standard Deviation 2020
|
7160 ng*d/mL
Standard Deviation 1900
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: AUC of Anti-HER3-ac-DXd
AUClast, Cycle 3
|
18300 ng*d/mL
Standard Deviation 2740
|
9360 ng*d/mL
Standard Deviation 3670
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: AUC of Anti-HER3-ac-DXd
AUClast, Cycle 4
|
—
|
23100 ng*d/mL
Standard Deviation 8130
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: AUC of Anti-HER3-ac-DXd
AUCtau, Cycle 1
|
6160 ng*d/mL
Standard Deviation 1160
|
7630 ng*d/mL
Standard Deviation 1920
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: AUC of Anti-HER3-ac-DXd
AUCtau, Cycle 3
|
16600 ng*d/mL
Standard Deviation 3760
|
11600 ng*d/mL
Standard Deviation 1880
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: AUC of Anti-HER3-ac-DXd
AUCtau, Cycle 4
|
—
|
22300 ng*d/mL
Standard Deviation 8010
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: AUC of Anti-HER3-ac-DXd
AUCinf, Cycle 1
|
6220 ng*d/mL
Standard Deviation 1200
|
7800 ng*d/mL
Standard Deviation 1990
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.
The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=30 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=29 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
n=21 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
n=30 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Part: AUC of Anti-HER3-ac-DXd
AUClast, Cycle 1
|
10500 ng*d/mL
Standard Deviation 2850
|
11500 ng*d/mL
Standard Deviation 3930
|
11100 ng*d/mL
Standard Deviation 4840
|
11400 ng*d/mL
Standard Deviation 3820
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part: AUC of Anti-HER3-ac-DXd
AUClast, Cycle 3
|
14200 ng*d/mL
Standard Deviation 6540
|
20000 ng*d/mL
Standard Deviation 14400
|
19300 ng*d/mL
Standard Deviation 6830
|
20400 ng*d/mL
Standard Deviation 6230
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part: AUC of Anti-HER3-ac-DXd
AUCtau, Cycle 1
|
10100 ng*d/mL
Standard Deviation 2480
|
11900 ng*d/mL
Standard Deviation 3400
|
11700 ng*d/mL
Standard Deviation 4430
|
11700 ng*d/mL
Standard Deviation 3380
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part: AUC of Anti-HER3-ac-DXd
AUCtau, Cycle 3
|
15600 ng*d/mL
Standard Deviation 6850
|
22400 ng*d/mL
Standard Deviation 12700
|
20300 ng*d/mL
Standard Deviation 6830
|
19800 ng*d/mL
Standard Deviation 5540
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were analyzed using the Pharmacokinetic Analysis Set.
The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
n=6 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Part: Maximum Plasma Concentration (Cmax) of Anti-HER3-ac-DXd
Cmax, Cycle 1
|
1040 ng/mL
Standard Deviation 217
|
1740 ng/mL
Standard Deviation 421
|
2950 ng/mL
Standard Deviation 661
|
3660 ng/mL
Standard Deviation 1080
|
4210 ng/mL
Standard Deviation 568
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Maximum Plasma Concentration (Cmax) of Anti-HER3-ac-DXd
Cmax, Cycle 3
|
948 ng/mL
|
1820 ng/mL
Standard Deviation 284
|
3020 ng/mL
Standard Deviation 572
|
3870 ng/mL
Standard Deviation 488
|
3720 ng/mL
Standard Deviation 973
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 4, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.
The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=12 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=12 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Finding Part: Cmax of Anti-HER3-ac-DXd
Cmax, Cycle 1
|
1980 ng/mL
Standard Deviation 300
|
2370 ng/mL
Standard Deviation 566
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: Cmax of Anti-HER3-ac-DXd
Cmax, Cycle 3
|
4230 ng/mL
Standard Deviation 1120
|
2830 ng/mL
Standard Deviation 760
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: Cmax of Anti-HER3-ac-DXd
Cmax, Cycle 4
|
—
|
4310 ng/mL
Standard Deviation 1120
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set
The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=33 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=30 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
n=21 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
n=31 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Part: Cmax of Anti-HER3-ac-DXd
Cmax, Cycle 1
|
3010 ng/mL
Standard Deviation 631
|
3520 ng/mL
Standard Deviation 619
|
3630 ng/mL
Standard Deviation 744
|
3610 ng/mL
Standard Deviation 878
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part: Cmax of Anti-HER3-ac-DXd
Cmax, Cycle 3
|
3020 ng/mL
Standard Deviation 606
|
4000 ng/mL
Standard Deviation 672
|
4150 ng/mL
Standard Deviation 892
|
4090 ng/mL
Standard Deviation 506
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were analyzed in the Pharmacokinetic Analysis Set.
The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
n=6 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Part: Time to Maximum Plasma Concentration (Tmax) of Anti-HER3-ac-DXd
Tmax, Cycle 1
|
1.85 hours
Interval 1.8 to 1.88
|
1.68 hours
Interval 1.65 to 2.05
|
1.83 hours
Interval 1.7 to 7.13
|
2.05 hours
Interval 1.68 to 22.83
|
1.98 hours
Interval 1.77 to 6.92
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Time to Maximum Plasma Concentration (Tmax) of Anti-HER3-ac-DXd
Tmax, Cycle 3
|
2.18 hours
|
1.83 hours
Interval 1.83 to 2.1
|
1.88 hours
Interval 0.73 to 2.08
|
2.03 hours
Interval 0.77 to 4.13
|
4.22 hours
Interval 2.02 to 6.92
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 4, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.
The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=12 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=12 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Finding Part: Tmax of Anti-HER3-ac-DXd
Tmax, Cycle 1
|
1.86 hours
Interval 1.6 to 4.23
|
2.01 hours
Interval 1.73 to 3.95
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: Tmax of Anti-HER3-ac-DXd
Tmax, Cycle 3
|
2.00 hours
Interval 0.82 to 4.0
|
1.93 hours
Interval 0.6 to 3.95
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: Tmax of Anti-HER3-ac-DXd
Tmax, Cycle 4
|
—
|
1.83 hours
Interval 0.73 to 6.95
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.
The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=33 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=30 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
n=21 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
n=31 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Part: Tmax of Anti-HER3-ac-DXd
Tmax, Cycle 1
|
1.90 hours
Interval 1.72 to 7.92
|
1.97 hours
Interval 1.6 to 3.98
|
1.98 hours
Interval 1.75 to 7.5
|
1.95 hours
Interval 1.67 to 6.78
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part: Tmax of Anti-HER3-ac-DXd
Tmax, Cycle 3
|
1.78 hours
Interval 0.63 to 7.1
|
0.93 hours
Interval 0.57 to 6.8
|
2.02 hours
Interval 0.7 to 7.02
|
2.03 hours
Interval 0.77 to 6.97
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were analyzed in the Pharmacokinetic Analysis Set.
The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
n=6 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Part: Area Under the Concentration-Time Curve of Total Anti-HER3 Antibody
AUClast, Cycle 1
|
114 ug*d/mL
Standard Deviation 14.7
|
219 ug*d/mL
Standard Deviation 61.0
|
416 ug*d/mL
Standard Deviation 128
|
635 ug*d/mL
Standard Deviation 171
|
847 ug*d/mL
Standard Deviation 248
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Area Under the Concentration-Time Curve of Total Anti-HER3 Antibody
AUClast, Cycle 3
|
111 ug*d/mL
|
312 ug*d/mL
Standard Deviation 124
|
700 ug*d/mL
Standard Deviation 234
|
1080 ug*d/mL
Standard Deviation 280
|
1570 ug*d/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Area Under the Concentration-Time Curve of Total Anti-HER3 Antibody
AUCtau, Cycle 1
|
114 ug*d/mL
Standard Deviation 14.5
|
219 ug*d/mL
Standard Deviation 61.0
|
408 ug*d/mL
Standard Deviation 115
|
671 ug*d/mL
Standard Deviation 169
|
848 ug*d/mL
Standard Deviation 248
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Area Under the Concentration-Time Curve of Total Anti-HER3 Antibody
AUCtau, Cycle 3
|
111 ug*d/mL
|
311 ug*d/mL
Standard Deviation 122
|
682 ug*d/mL
Standard Deviation 194
|
1050 ug*d/mL
Standard Deviation 249
|
1200 ug*d/mL
Standard Deviation 450
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Area Under the Concentration-Time Curve of Total Anti-HER3 Antibody
AUCinf, Cycle 1
|
115 ug*d/mL
Standard Deviation 14.3
|
226 ug*d/mL
Standard Deviation 67.3
|
447 ug*d/mL
Standard Deviation 153
|
729 ug*d/mL
Standard Deviation 186
|
839 ug*d/mL
Standard Deviation 203
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 4, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.
The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=11 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=11 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Finding Part: Area Under the Concentration-Time Curve in Total Anti-HER3 Antibody
AUClast, Cycle 3
|
933 ug*d/mL
Standard Deviation 174
|
486 ug*d/mL
Standard Deviation 199
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: Area Under the Concentration-Time Curve in Total Anti-HER3 Antibody
AUClast, Cycle 4
|
—
|
1110 ug*d/mL
Standard Deviation 280
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: Area Under the Concentration-Time Curve in Total Anti-HER3 Antibody
AUCtau, Cycle 1
|
253 ug*d/mL
Standard Deviation 58.0
|
341 ug*d/mL
Standard Deviation 103
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: Area Under the Concentration-Time Curve in Total Anti-HER3 Antibody
AUClast, Cycle 1
|
235 ug*d/mL
Standard Deviation 92.7
|
302 ug*d/mL
Standard Deviation 87.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: Area Under the Concentration-Time Curve in Total Anti-HER3 Antibody
AUCtau, Cycle 3
|
839 ug*d/mL
Standard Deviation 220
|
616 ug*d/mL
Standard Deviation 138
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: Area Under the Concentration-Time Curve in Total Anti-HER3 Antibody
AUCtau, Cycle 4
|
—
|
1090 ug*d/mL
Standard Deviation 276
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: Area Under the Concentration-Time Curve in Total Anti-HER3 Antibody
AUCinf, Cycle 1
|
260 ug*d/mL
Standard Deviation 63.4
|
335 ug*d/mL
Standard Deviation 102
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.
The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=31 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=26 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
n=20 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
n=30 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Part: Area Under the Concentration-Time Curve in Total Anti-HER3 Antibody
AUCtau, Cycle 1
|
483 ug*d/mL
Standard Deviation 140
|
564 ug*d/mL
Standard Deviation 178
|
580 ug*d/mL
Standard Deviation 200
|
542 ug*d/mL
Standard Deviation 158
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part: Area Under the Concentration-Time Curve in Total Anti-HER3 Antibody
AUClast, Cycle 1
|
525 ug*d/mL
Standard Deviation 174
|
570 ug*d/mL
Standard Deviation 248
|
543 ug*d/mL
Standard Deviation 225
|
528 ug*d/mL
Standard Deviation 166
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part: Area Under the Concentration-Time Curve in Total Anti-HER3 Antibody
AUClast, Cycle 3
|
831 ug*d/mL
Standard Deviation 391
|
1070 ug*d/mL
Standard Deviation 656
|
1070 ug*d/mL
Standard Deviation 381
|
1000 ug*d/mL
Standard Deviation 266
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part: Area Under the Concentration-Time Curve in Total Anti-HER3 Antibody
AUCtau, Cycle 3
|
874 ug*d/mL
Standard Deviation 365
|
1200 ug*d/mL
Standard Deviation 536
|
1030 ug*d/mL
Standard Deviation 366
|
940 ug*d/mL
Standard Deviation 243
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were assessed in the Pharmacokinetic Analysis Set.
The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
n=6 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Part: Cmax of Total Anti-HER3 Antibody
Cmax, Cycle 1
|
39.8 ug/mL
Standard Deviation 9.55
|
61.6 ug/mL
Standard Deviation 8.41
|
95.8 ug/mL
Standard Deviation 13.5
|
136 ug/mL
Standard Deviation 26.8
|
149 ug/mL
Standard Deviation 35.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Cmax of Total Anti-HER3 Antibody
Cmax, Cycle 3
|
37.6 ug/mL
|
66.8 ug/mL
Standard Deviation 11.2
|
112 ug/mL
Standard Deviation 14.1
|
149 ug/mL
Standard Deviation 24.7
|
165 ug/mL
Standard Deviation 25.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 4, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.
The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=12 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=12 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Finding Part: Cmax of Anti-HER3 Antibody
Cmax, Cycle 1
|
67.9 ug/mL
Standard Deviation 11.3
|
87.2 ug/mL
Standard Deviation 33.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: Cmax of Anti-HER3 Antibody
Cmax, Cycle 3
|
139 ug/mL
Standard Deviation 25.0
|
94.9 ug/mL
Standard Deviation 10.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: Cmax of Anti-HER3 Antibody
Cmax, Cycle 4
|
—
|
145 ug/mL
Standard Deviation 16.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were assessed in participants with available data in the Pharmacokinetic Analysis Set.
The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=33 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=30 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
n=21 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
n=31 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Part: Cmax in Anti-HER3 Antibody
Cmax, Cycle 1
|
107 ug/mL
Standard Deviation 20.3
|
129 ug/mL
Standard Deviation 21.2
|
126 ug/mL
Standard Deviation 28.4
|
127 ug/mL
Standard Deviation 24.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part: Cmax in Anti-HER3 Antibody
Cmax, Cycle 3
|
121 ug/mL
Standard Deviation 27.7
|
152 ug/mL
Standard Deviation 25.8
|
140 ug/mL
Standard Deviation 29.7
|
146 ug/mL
Standard Deviation 21.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were assessed in the Pharmacokinetic Analysis Set.
The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=3 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
n=15 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
n=6 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Part: Tmax of Total Anti-HER3 Antibody
Tmax, Cycle 1
|
1.85 hours
Interval 1.8 to 2.17
|
1.68 hours
Interval 1.65 to 1.7
|
1.95 hours
Interval 1.7 to 6.87
|
2.00 hours
Interval 1.82 to 7.0
|
2.14 hours
Interval 1.77 to 6.92
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Tmax of Total Anti-HER3 Antibody
Tmax, Cycle 3
|
2.18 hours
|
1.83 hours
Interval 1.83 to 2.1
|
1.88 hours
Interval 0.67 to 6.88
|
2.02 hours
Interval 0.75 to 96.42
|
2.07 hours
Interval 2.02 to 2.13
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 4, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.
The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=12 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=12 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Finding Part: Tmax of Anti-HER3 Antibody
Tmax, Cycle 1
|
1.85 hours
Interval 1.6 to 4.07
|
1.80 hours
Interval 1.73 to 6.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: Tmax of Anti-HER3 Antibody
Tmax, Cycle 3
|
3.80 hours
Interval 0.75 to 6.97
|
1.93 hours
Interval 0.65 to 4.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Finding Part: Tmax of Anti-HER3 Antibody
Tmax, Cycle 4
|
—
|
3.80 hours
Interval 0.67 to 4.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)Population: Pharmacokinetic data were assessed in participants with available data in the Pharmacokinetic Analysis Set.
The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.
Outcome measures
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=33 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=30 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
n=21 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
n=31 Participants
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Part: Tmax in Anti-HER3 Antibody
Tmax, Cycle 1
|
1.92 hours
Interval 1.75 to 6.8
|
2.00 hours
Interval 1.6 to 4.13
|
1.87 hours
Interval 1.75 to 6.8
|
1.93 hours
Interval 1.67 to 22.02
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part: Tmax in Anti-HER3 Antibody
Tmax, Cycle 3
|
1.95 hours
Interval 0.68 to 6.97
|
2.10 hours
Interval 0.73 to 7.17
|
1.98 hours
Interval 0.73 to 6.98
|
2.00 hours
Interval 0.65 to 6.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Dose Escalation: Cohort 1.6 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Dose Escalation: Cohort 3.2 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
Serious events: 3 serious events
Other events: 15 other events
Deaths: 13 deaths
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
Serious events: 9 serious events
Other events: 15 other events
Deaths: 11 deaths
Dose Escalation: Cohort 8.0 mg/kg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Dose Finding: 3.2/4.8/6.4 mg/kg
Serious events: 4 serious events
Other events: 12 other events
Deaths: 10 deaths
Dose Finding: 4.2/6.4 mg/kg
Serious events: 3 serious events
Other events: 12 other events
Deaths: 10 deaths
Dose Expansion: HER3 High 4.8 mg/kg
Serious events: 10 serious events
Other events: 32 other events
Deaths: 22 deaths
Dose Expansion: HER3-High 6.4 mg/kg
Serious events: 12 serious events
Other events: 31 other events
Deaths: 24 deaths
Dose Expansion: HER3-Low 6.4 mg/kg
Serious events: 7 serious events
Other events: 21 other events
Deaths: 18 deaths
Dose Expansion: TNBC 6.4 mg/kg
Serious events: 8 serious events
Other events: 31 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=3 participants at risk
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=3 participants at risk
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
n=15 participants at risk
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
n=15 participants at risk
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
n=6 participants at risk
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
n=12 participants at risk
Participants who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
n=12 participants at risk
Participants who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
n=33 participants at risk
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
n=31 participants at risk
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
n=21 participants at risk
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
n=31 participants at risk
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Implant site infection
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.7%
3/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.5%
2/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Psychiatric disorders
Delirum
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
General disorders
Disease progression
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Troponin increased
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
Other adverse events
| Measure |
Dose Escalation: Cohort 1.6 mg/kg
n=3 participants at risk
Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 3.2 mg/kg
n=3 participants at risk
Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 4.8 mg/kg
n=15 participants at risk
Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation/Dose Finding: Cohort 6.4 mg/kg
n=15 participants at risk
Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Escalation: Cohort 8.0 mg/kg
n=6 participants at risk
Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
|
Dose Finding: 3.2/4.8/6.4 mg/kg
n=12 participants at risk
Participants who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Finding: 4.2/6.4 mg/kg
n=12 participants at risk
Participants who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
|
Dose Expansion: HER3 High 4.8 mg/kg
n=33 participants at risk
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-High 6.4 mg/kg
n=31 participants at risk
Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: HER3-Low 6.4 mg/kg
n=21 participants at risk
Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
Dose Expansion: TNBC 6.4 mg/kg
n=31 participants at risk
Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
General disorders
Peripheral sweling
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
General disorders
Feeling abnormal
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.7%
3/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Weight increased
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Troponin T increased
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Eye disorders
Corneal disorder
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
40.0%
6/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
26.7%
4/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
25.0%
3/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
25.0%
3/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
15.2%
5/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.7%
3/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
23.8%
5/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.7%
3/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.1%
3/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.7%
3/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
14.3%
3/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.7%
3/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Influenza
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.7%
3/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Infections and infestations
Implant site infection
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
53.3%
8/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
53.3%
8/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
50.0%
3/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
4/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
39.4%
13/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
61.3%
19/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
23.8%
5/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
32.3%
10/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
2/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
12.1%
4/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
25.8%
8/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
19.0%
4/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
19.4%
6/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
2/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
12.1%
4/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
25.8%
8/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
19.0%
4/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.7%
3/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.5%
2/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.7%
3/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Immune system disorders
Iodine allergy
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
66.7%
2/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
60.0%
9/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
73.3%
11/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
66.7%
4/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
41.7%
5/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
4/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
54.5%
18/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
48.4%
15/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
38.1%
8/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
58.1%
18/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
20.0%
3/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
4/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
24.2%
8/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.7%
3/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
19.0%
4/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
26.7%
4/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
20.0%
3/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
18.2%
6/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.1%
5/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.5%
2/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
15.2%
5/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
12.9%
4/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
12.1%
4/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.1%
3/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
20.0%
3/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
4/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
18.2%
6/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.7%
3/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
12.9%
4/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
5/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
12.9%
4/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.1%
3/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
12.9%
4/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
14.3%
3/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.5%
2/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.1%
3/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.5%
2/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Eye disorders
Dry eye
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
2/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.1%
3/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
12.9%
4/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Eye disorders
Keratitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Eye disorders
Conjunctival deposit
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Eye disorders
Strabismus
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
40.0%
6/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
12.1%
4/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.1%
5/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
28.6%
6/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
20.0%
3/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.5%
2/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.7%
3/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
100.0%
3/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
73.3%
11/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
93.3%
14/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
100.0%
6/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
100.0%
12/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
83.3%
10/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
66.7%
22/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
80.6%
25/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
71.4%
15/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
80.6%
25/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
66.7%
2/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
53.3%
8/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
60.0%
9/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
66.7%
4/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
4/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
25.0%
3/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
45.5%
15/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
41.9%
13/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
7/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
54.8%
17/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
5/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
53.3%
8/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
41.7%
5/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
50.0%
6/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
45.5%
15/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
45.2%
14/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
7/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
45.2%
14/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
100.0%
3/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
40.0%
6/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
46.7%
7/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
2/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
18.2%
6/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.1%
5/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
47.6%
10/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
38.7%
12/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
20.0%
3/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
5/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
50.0%
3/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
4/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
24.2%
8/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
35.5%
11/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
28.6%
6/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
22.6%
7/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
20.0%
3/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.5%
2/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.7%
3/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.1%
3/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.5%
2/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.5%
2/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.1%
3/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.5%
2/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
20.0%
3/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
5/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
66.7%
4/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
21.2%
7/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
29.0%
9/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
28.6%
6/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
25.8%
8/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
5/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
12.1%
4/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
14.3%
3/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.7%
3/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
14.3%
3/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.1%
5/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.5%
2/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
50.0%
3/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.5%
2/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Skin sensitisation
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
12.1%
4/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
12.9%
4/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
14.3%
3/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
15.2%
5/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
14.3%
3/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.5%
2/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Musculoskeletal and connective tissue disorders
Pubic pain
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
5/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
5/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
2/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
41.7%
5/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
30.3%
10/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
32.3%
10/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
38.1%
8/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
32.3%
10/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
53.3%
8/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
2/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
25.0%
3/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
27.3%
9/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.1%
5/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
14.3%
3/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
32.3%
10/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
20.0%
3/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
15.2%
5/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
19.4%
6/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
19.0%
4/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
12.9%
4/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
5/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.1%
3/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
20.0%
3/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.1%
3/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
General disorders
Oedema
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
General disorders
Performance status decreased
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
66.7%
10/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
86.7%
13/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
50.0%
3/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
4/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
4/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
45.5%
15/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
41.9%
13/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
52.4%
11/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
54.8%
17/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
66.7%
10/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
86.7%
13/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
2/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
66.7%
8/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
25.0%
3/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
45.5%
15/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
32.3%
10/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
38.1%
8/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
48.4%
15/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
60.0%
9/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
93.3%
14/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
2/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
50.0%
6/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
36.4%
12/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
32.3%
10/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
7/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
32.3%
10/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
66.7%
10/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
46.7%
7/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
50.0%
3/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
25.0%
3/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
11/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
35.5%
11/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
28.6%
6/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
32.3%
10/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
60.0%
9/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
26.7%
4/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
50.0%
3/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
11/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
32.3%
10/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
7/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
32.3%
10/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
24.2%
8/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
22.6%
7/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.7%
3/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
20.0%
3/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
20.0%
3/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.1%
5/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.5%
2/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
26.7%
4/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
18.2%
6/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.7%
3/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
2/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
26.7%
4/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.1%
3/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
13.3%
2/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Blood creatinine phosphokinase increased
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Blood pressure increased
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Investigations
Blood electrolytes decreased
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
16.7%
1/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
33.3%
1/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Injury, poisoning and procedural complications
Radiation fibrosis - lung
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.7%
1/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
14.3%
3/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.5%
2/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.1%
3/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.1%
3/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
19.4%
6/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.5%
2/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
9.5%
2/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Gastrointestinal disorders
Hyperaesthesia teeth
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.1%
2/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
8.3%
1/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.0%
1/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
3.2%
1/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/3 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/15 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/6 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/12 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/33 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
6.5%
2/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
4.8%
1/21 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
0.00%
0/31 • Adverse events were collected from baseline up to 28 days post last dose, up to 9 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place